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Food and Drug Administration
FDA Logo
?????? ????????
???? 1906 [?]
Preceding agencies Food, Drug, and Insecticide Administration (July 1927 to July 1930)
Bureau of Chemistry, USDA (July 1901 through July 1927)
Division of Chemistry, USDA (Established 1862)
????????????? Federal government of the United States
????? ??? 10903 New Hampshire Ave, Silver Spring, MD 20903
Employees 9,300 (2008)
??????? ????????? $2.3 billion (2008)
???????? ????????? Margaret A. Hamburg , Commissioner of Food and Drugs [?]
Parent Agency Department of Health and Human Services
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fda.gov

????? ??? ??? ??????????? ( ????? (FDA) ???? ????????? (USFDA) ) ? ???????? ??????? ???????????? ?? ????? ???? ?????? ?????????? ?????? ??. ?? ???????? ??????? ????? ???????????? ???????????????? ?? ?????? ??. ???? ???? ????? ??????, ??????? ??????, ???? ?????, ?????????????? ??? ???-?-??????? (????? ?????? ???? ??????) ???? (????), ????, ????????????????????, ???? ????????????? (?? ????????? ????????? ???? ????????? ??????? ?????? ???????), ????? ?????, ?????????????? ?????? ???????? ????? (??????) (ERED), ?????? ????? ????? ?????? ?????????, ??? ??????????? ???? ??????? ????? ??? ???? ?? ?????? ?????? ????? ???????? ????? ?????? ??? ???? ?????????? ?????? ???????? ??.

????? (FDA) ???? ?????? ????? ?? ??? ????? ????? ?????? ???? ??????? ??? 361 ??? ???? ??????? ????????? ???? ????? ?? ??????? ??? ????? ????? ??? ??? ???? ???? ????????? ???. ????? ????????? ????????? ?????? ???????? ??? ?????? ????? ?????? ???????? ???? ????? ?????? ???? ???????? ?????? ????????? ?? ????? ??????? ?????? ??? ??. ????? (FDA)??? ????????? ?????? ?? ??? ???? ?????? ??? ?? ???? ???????? ??????? ???? ??? ?????? ???? ?????? ?????? ???? ??. ?????? ????????? ?? ????? ???? ?????? ???????? ???? ??? ??? ??. ???????? 21??? ?????? ??. ????????? ? ???????? ??. ??? ????????? 2009?? ?????? ????? ??? ????? ?????? ??.

????? (FDA) ?????? ????????, ????????? ???? ????? ???????? ????? ?? ??? ???? 50 ??????? ??? ???????? ??????? ?????? ???????, ??? ???????? ??????? 223 ????? ???? ??? 13 ??????????? ????? ??. [?] 2008??? ????? (FDA)? ???, ???? , ?????? ????, ???? , ????????, ??? ???????? ?????? ???? ?????? ??????????? ?????? ???????? ??? ?????? ????. [?]

????? [ ?????? ??? ]

????? (FDA) ?????? ?????? ??? ???????? ????? ??. ?? ???? ???? ??.

  • ???? ?? ? ??????
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  • ?????? ??? ?????? ???? ???????????? ????? (????????)(CDRH)
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      • ???????????? ???? ?????? ????? (????????) (RDRC) ?????????
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        • ?????? ?? ???????? ???????? ??????
          • ????????????? ???? ???????????? ????? ???????? ????? (?????????) (ICSAS)
    • ???? ?? ????????? ???? ????????????? (?????? ???? ?? ???? ??????)
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    • ?????? ?? ???? ??????????
      • ????? (FDA) ??????? ???????? ?????????????? ?????????
    • ??????? ?????? ???
    • ?????? ????? ???
  • ?????? ??? ??? ????? ???? ??????? ??????????
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  • ???? ?? ??????????? ??????

????????? ??????? ?????????? ????? ???? ????? ???????? ????????? ???????????? ????? ??? ?????? ????????, ??????????? ?????? ?? ???? ????? ???? ???????? ??????????? ???? ?????? ??????? ????? ?????? ??????? ???????? ??????????? ??? ???? ????????? ??????? ?????? ???? ???? ?????? ??? ??? ??. ?????? ????? (FDA) ??? ?????? ??????? ??? ?????? ?? ???? ????? ???????? ?????? ????? ?????? ?????? ?? ?????? ?? ??????? ??????. ???????? 2003??? ?? ????? ?????, ???? ?????? ????????? 104 ????????? ???? ????? ??????? ??? ??? ?????? ???????? ???. ? ????????? 2013 ??????? ????? ????? ???.

????? ????????? ??????? ??? ????? ???? ????? ??????? ????????? ??.??. ????????? ????? ????? ?? ?????? ?? ????? - ???? ?? ??????????? ?????? (????)(???? (ORA)) ??? ???? ?? ???????? ??????????????? (?????) (????? (OCI)) - ????? ?????? ????????? ?????? ????? ????? ??.

???? ?? ??????????? ???????? ???????? '??? ??? ???" ??????? ??? ??. ?? ???????? ????? (FDA)?? ???? ????? ??????? ??? ??. ????????? ?????? ?????, ??????? ???? ???? ??????? ????? ????? ??, ??? ???????? ?? ?? ??????? ??? ???? ???????? ???? ??? ??, ???????, ?????? ???? ????????? ???? ??? ?? ??? ????? ??????, ????, ????? ???????? ??? ????? ????? ???? ??? ???? ???? ?????????? ????? ????? ????? ???? ??? ???? ???? ???????? ????????? ?????????????? ??????? ??? ??. ???? ?? ??????????? ?????? ???? ??????? ?????????? ?? ?? ??? 13 ????????? ??????? ??. ??????????????? ???? ???? ??? ????? ????? ???????? ??????? ?????? ?? ??? ??. ???????? ??????????? ?? ????? ??????????? ???? ??? ???? ???????? ??????? ????? ??, ?? ?????? ??????? ?????????? ???? ???? ?????? ??????????? ?????? ??? ????? ????? (FDA)?? ????? ??. ???? (???? (ORA))??? ???????? ???????????? ??????? ?? ?????? ??? ?? ?? ???????? ??? ?? ????? ???????? ???????? ??? ??. ????? ???? ???? ??????? ???? ??? ?? ??? ???? ?????? ??????????? ????, ??????????? ??? ???????? ???????? ???? ????????? ???????? ???? ???? ???? ??.

???? ?? ???????? ????????????????? ??????? ?????? ???? ???? ???? 1991??? ??????? ??????? ??? ???. ???? (ORA) ???? ?????????? ?????? ????? (OCI) ???????? ?????? ?????????? ??? ?? ??? ??? ????????? ????????? ?????? ????? ?? ??? ????? ???. ????? (OCI) ?????? ??? ???? ????? ??? ?? ????? ?????? ????????? ?? ?? ????? ????????????? ??? ???? ????????? ?????????? ?????????? ?????????? ??????? ??? ??????????? ?????. ??? ??????? ????? (OCI) ??? ???? ?????? ????? ????? 18?? ??? ??? ??.(??.?. ???????, ???? ???????, ???? ?????????, ???? ?????????). ??? ???? ???? ?? ?????? ?????? 3??? ??????????? ??????? ????? ?????????? ??????? ?????? ?? ??? ????? ??.????? (OCI) ???????? ?????? ?????? ???? ??????? ?????? ????????????? ?????? ??? ?? ??? ????? ?????? ?? ?????????????, ????????? ?????? ????, ??? ???????? ???? ???????? ??? ??? ??. ????? (OCI) ????? ??????? ?????? ??? ????? ?? ????? ???? (ORA), ??????? ??????? ??? ?????? (FBI)?? ?????? ??? ??. ?? ????? ?????? ??? ??????? ?????? ????? ????? ???? ???? (ORA) ???? ???????? ???? ??? ????. ????? (OCI) ?? ???? ???? ?? ?? ???????? ???? 200 ????? ????? ??.

????? (FDA) ?????? ???????????? ?? ??????????, ???? ???????????? ??????????????, ??????? ???? ?????? ??????????, ??? ????????? ???????? ?????? ????? ???? ????? ??????? ???? ?? ???????? ??? ??? ??. ????????? ?????? ????? ??? ??????? ?????? ??????? ???? ????? ?????? ??????? ??? ????? ??????? ??????? ?? ????? (FDA)?? ??????? ??? ??? ??.

????? ??? ????? [ ?????? ??? ]

????? (FDA) $1 ?????????? ??? ??????? ????????? ???????? ????? ??? ??, ????? ????? ????????? ?????? ?????? ???? 25 ??? ?????? ??? ??. ????? ?????????????? ???????? $466 ???, ?????? $275 ???, ?????????????? $60 ??? ??? ??????? ???? ?????????? $18 ????? ?????? ??? ??. ???? ????? ???? ?????????? ???? ??? ???????? ???? ??; ????? (FDA) ???? ?????? ????? ???? ?? ??? ??????? ???????? ??. [?]

??????? ???? 2008 ???? ????? (FDA)?? ????????? ??????????? ??????? (??????? 2007?? ????????? 2008 ????) $2.1 ????? ??? ?? ???? ??????? ???? 2007??? ??????? ?????? ???? $105.8 ?????? ??? ???. [?] ????????? 2008??? ????? (FDA)? ??????? ??? ??? ?? ????? ?????? ??????? ??????? ???? 2009 ?????? ??????????? ??????? $2.4 ??? ???? ?? ??? ???: ????? $1.77 ????? ?????? ????????? ????? (????????? ?????) ??? $628 ???????? ?????? ???? ????? ?? ???. ??????? ??????? ????????? ????? ??????? ???? 2008?? ?????? ???? $50.7 ?????? ???? ?? ???? ???? ??? ??? ???. ??? 2008??? ????????? ???????? ??????? ???? ??????? ???? 2008 ???? $150 ?????? ??? ??????? ???? 2009 ???? ??? $150 ?????? ????? ???. [?]

?????? ????? [ ?????? ??? ]

????? (FDA)?? ???? ???? ????? ????????? ?????? ???, ???? ???? ????????? ?????? ??? ?? [?] (?? ?? ????? 1938??? ???? ??? ??? ??? ????? ?????? ????? ??? ?????? ??? ????? ??) ??? ???? ???????? ??????? ????? ????? 21, ?????? 9??? ?????? ????? ??.. ????? (FDA) ?????? ?????? ????? ???? ????????? ????????? ????? ?????? ???? ?????, ?????????? ???????? ?????? ???, ????? ?????-????????? ????, ???? ???? ??? ???????? ?????? ??? ??. ??? ?????????? ? ????????? ???? ????????? ??????? ???? ?? ?????????? ??? ??.

????? (FDA)?? ??????? ???? ????????? ?????? ???? ?????? ???????? ?????? ??? ??:

  • 1902? ??????????? ???????? ????
  • 1906? ????? ??? ???? ???? ????
  • 1938? ????? ???, ????, ???? ????????? ????
  • 1944? ????? ?????? ???? ?????
  • 1951? 1951 ???, ???? ???? ??????????? ???? ????????????? PL 82?215
  • 1962? 1962 ???, ???? ???? ??????????? ???? ????????????? PL 87?781
  • 1966? ??? ???????? ???? ??????? ???? PL 89?755
  • 1976? ?????? ?????? ?????????? ???? PL 94?295
  • 1987? ?????????????? ???? ?????????? ????
  • 1988? ?????????? ?????? ???? PL 100?690
  • 1990? ?????????? ??????? ???? ????????? ???? PL 101?535
  • 1992? ?????????????? ???? ???? ???? ???? PL 102?571
  • 1994? ??????? ?????????? ????? ???? ????????? ????
  • 1997? ????? ??? ??? ??????????? ????? (FDA) ???????????? ???? 105-115
  • 2002? ??????????? ???? 107-188
  • 2002? ?????? ?????? ???? ?? ???? ???????????? ???? (???????????)(MDUFMA) PL 107-250
  • 2003? ????? ???? ???? ?? ???? PL 108-130
  • 2007? ????? ??? ??? ?????? ????? (?????) (FDA)????????????? ???? ?? 2007
  • 2009? ?????? ???????? ?????????? ???? ?????? ???????? ????

????? ?????? ?????????? [ ?????? ??? ]

????? ????? ?????? ????????????? ????????? ??????, ???? ?????? ????? ??? ???????? ??????? ??????? ???????? ????? ??????? ???? ??? ??. ??? ??, ????? (FDA) ?????????????? ?????? ???? ???? ????????? ????? ???? ??, ????? ????????, ???????, ???????, ????????????, ??????????, ?????? ??? ?????? ????? ????-???? ???????? ?????? ??? ??. ????? ????? (FDA)??? ????? ????????????? ?????????? ????? ??????? ??? ?????? ?? ? ????? ??? ??. ????? (FDA) ?????? ??????????? ?????? ?????? ???????? ??????? ?????? ???? ????? ????????????? ????? ??? ??. ????????????? ????????? ????? 483 ????????? ????? ??.

????? ??? ???? ???? [ ?????? ??? ]

????? ???: Regulation of food and dietary supplements by the U.S. Food and Drug Administration

? ?????? ??? ??? ????? ???? ??????? ?????????? ? ????? (FDA)?? ???? ??, ?? ???????? ?????????? ???? ???? ????? ?????????? ????? ??? ?????????????? ????????? ??????? ?????? ??. [?] ?????? ???? ??? ???? ???? ???????? ????? ????????? ?????? ???????? ????? ????? ??. ? ?????????? ????????? ???????? ???????? ??????? ???????????? ?? ?????????? ??? ????? ???? ?????????? ?????? ?????? ??. ???? ???? ????????? ??? ????? ??????????? ????? ????? (FDA) ?????? ?? ??? ???? ??????? ??????? ?????????? ?? ?????????????????? ?? ???? ???? ???? ??? ??. ????, ???? ????? ????????? ????? ???? ??? ???? ??????????? ????? ????? (FDA)?? ???? ???? - ? ?????? ??? ??????? ??????? ?????? ??. ????? (FDA) ?? ???????? ??? ????? ???? ??????????? ??? ????? ????? ???????? ??????? ????? (???????????? ?? ???????? ?????? ?? ????????, ??????, ??????????, ?????? ???? ???????????? ?????? ?????) ??? ???-?????? ?????? ???? (???????? ??????? ?????????????? ????????? ?????? (???? (EPA) ?????? ?????????)?? ?????? ??? ??.

????????? (CFSAN)?? ????????????? ???????????? ???? ?????? ???? ??? ?????? ??? ??, ????? ?????? (????? ?????, ?????????? "??????" ???? ???? ?????? ???) ??? ?????????? ?????? ??????? ??????. ????????? (CFSAN) ???? ????? ?????????????? ????????????? ??????? ?????? ??? ?? ????? ??? ??. ?????????????? ?????? ??? ???? ???????? ??????? ???? ??? ?? ????? ?????????????? ???? ??.

??????? ?????????? ????? ???? ????????? ???? 1994?? ?????? ???? ????? (FDA)? ?????????????? ????? ?????? ??????? ?????????? ????? ????? ????? ????. ???? ??????? ?????????????? ?????? ??? ??????????? ?????? ?????? ????? ??? ??? ???? ???? ?????? ???????? ???? ???. ????? (FDA) ??????? ???????????? ???? ?????? ? ???? ??? ??? ?? ?? ?????? ?? ????? ?????? ??? ??????? ?????????????? ?????????? ?????? ????? ???? ????????? ???? ?????? ??? ??. ???? ? ?????????? ???? ?? "????????? ???? ????? ????" ??? ??. ??? ?????? ??????, ?????, ????? ???? ?????? ?????? ???? ??? ???? ??? ??? ???? ?? ???? ??? ???? ?????? ????? ?????? ??. [?]

?????????? ???????? ????? ?????? ??????? ????? (FDA) ?????? ????? ??? ??. [??] ????? ?????? ?? ???????? ????? ??????? ????? ??? ??. ???? ??????? ????? ????? ??? ??????? ????? ?????? ????? ??? ?? ??? ?? ???????? ??????? ???? (EPA). ???????? ????? ???? ?????? ????? (FDA) ????? ??????? ???? ???? (EPA)?? ?????????????? ?????? ?? ??? ????? (FDA) ?????? ??? ???? ????? ?? ??? ?? ???? (EPA)?? ??? ???? ????? ???????? ????? ?????? ???? ??? ??? ??. [??]

???? [ ?????? ??? ]

?????? ??? ???? ?????????? ???? ?????? ??? ????, ?????? ???? ??? ??? ? ??????? ???? - ? ???? ????? ??? ???????? ???? ????? ????????? ????? ??. ?? ??? ???? ??????? ?????? ????????? ??? ???, ????? ??????????? ???? ????????? ???? ?????? ???, ???? ????? ???? ????? ??? ???, ???? ????? ????????? ?????? ??????? ????? ??? ???? ????? ‘???’ ??????? ??? ??. ‘???? ????????? ????????’ ?????? ???????? ???? ??? ????? ??? ??. ?? ??? ???? ??? ???? ???? ??, ?? ??????? ?????????? ??????? ? ???????? ????? ???.

??? ???? [ ?????? ??? ]

??? ?????? ????? (FDA)?? ??????? ??? ?? ???? ?? ???? ?????, ???????? ???? ??????? ??? ??, ? ??????????? ???? ???? ?????????, ???? ?? ????? (NDA) ??? ??. ??? ???? ????? ?????????????? ?????? ? ??? ??? ??. ??? ? ??????? ????? (OTC) ??? ????????? ??, ?? ?????? ??? ???? ??????? ?????? ?????? ??? ??. ?????????????? ??? ???? ‘????? ???? ????? ????? ???????????? ??? ???????’ ?? ?????? ??.

??????? ??? ?????? [ ?????? ??? ]

????? (FDA) ????? ??????? ??? ???????????? ??? ?? ?????? ???? ??. (??? ? ??????? ???? ?????? ?????? ???? ???????? ?????????? ????? ????? ????? ????? ?????? ??? ??.). ????? ?????????? ????? [??] ?? ??????? ???? ????? ??. ???? ????? ?????????????, ????? ????? ?? ??????? ????? ???? ????? ????? ?????? ?????? ??? ???, ?? ????? ???? ? ???? ??????? ??? ??? ??. ???, ??????? ???? ???? ????? ????? ??? ????? ? ???? ????? "????? ??????" ??????? ????.

????? (FDA) ?????? ????? ????? ???? ?? ??????????? ?????? ??? ???, ?? ??????? ???? ??????????? ????? ???? "?? ????" ?????????? ????? ??.

????? ??? ?????? ???? ?????? [ ?????? ??? ]

????? (NDA)?? ?????? ??????? ??? ?????????? ????? ?????? ????? ???????? ???? ????? ??????? ??? ?????? ????? (FDA)?? ???? ??? ??. ????? ??????, ????? ??? ?????? ?????? ???? ???? 15 ?????? ???? ??? ?????? ??? ??, ????? ???? ???????????? ????????? ????? ??? ?????? ??? ??. [??] ????? (FDA) ????? ???? ????? ???? ?????? ???? ?????? ????????? ?????? ?? ????? ??. [??] ? ???????? "???????????? ??????" ???????? ??? ??, ???? ??, ??????? ?? ????? ??????????? ?????? ????????? ?????? ????????? ??? ??. ??? ??????? ??????? ??? ?????? ??????? ? ????? ???? ??, ?????? ?????????? ????? ???? ?????????? ?????? ????? (FDA)?? ????????? ??? ??? ??. ??????? ?????? ???? ????????? ??????? ??????? ??????? ??? ???? ??? ????? ?? ???, ??? ????????? “???? ???????? ???????” (???-4 ????????) ???????? ??? ??. ???? ???????? ???????, ????????? ???? ?? ?????????? ?????? ????? ??? ???? ?????? ?????? ??????? ????? (FDA)? ???? ?????????? ????? ??? ???? ??? ??.

?????? ???? [ ?????? ??? ]

?????? ???? ????? ???????? ???? ???? ?? ???? ??? ???? ???-??????? ???? ???? ?????? ?????? ?????? ??. [??] ?????????? ????? ?????? ???-??????? ???? ????? ????? ????? ??? ??? ??, ????? ??????? ??? ????? ???? ?????? ?????? ???? ??? ??, ??? 1990?? ???????? ???????? ?????????? ?????? ?????????????? ?????? ????, ????? ? ??????? ?????? ???? ?????? ?????? ????. [??] ?????? ????? ?????? ?????? ???? ???? ????? ??? ??? ?????? ????? (????? (FDA))?? ?? ????????? ?????? ???? ????? ??? ?? ??, ?? ????? ????? ????? ??????? ????? ???? ??? ?? ??? ???? ????? ?????? ???? ??. [??] ???? “??????" (ANDA) (???????????? ???? ???? ?????????) ??? ??.

?????? ??????? ?????? [ ?????? ??? ]

1989??? ?????? ?????? ??????? ????? ???? ???? ????? (FDA) ?????? ???????? ???????????? ???????? ????? ?????? ???? ?????? ????. [??] ????? (FDA)??? ?????? ?????? ??????? ?????? ????? ?????? ??????? ?????????? ?????? ?????? ????? ?????? 1988??? ??? ???. ????????? ????? ????? ?????????? ????. ?????? ????? (FDA) ??????? ??????? ????? ???????? ????????????? ?????? ????? ???? ???????? ??????? ???? ?????? ???? ?????? ??????? ????????? ????. ????????? ??????? ?????? ???? ???? ????? (FDA) ?????? ??????? ???? ???????? ???? ??? ?????? ???? ??????? ?? ???? ???? ??????? ?? ????? ?? ??? ??????? 1987??? ?????? ???? ? ????? (FDA) ???? ????? ???? ??? ??? ???. ???? ?????? ????? (FDA)?? ?? ???????? ????????? ??? ??? ??? ??????? ?????? ???? ???? ??????? ??? ??? ???? ?????? ??? ?? ????? ???????? ???? ???????? ???? ??????? ?????? ??? ????????????? ???????? ?????????? ?????? ??. "??? ???????? ???? ???? ??? ?? ?????? ? ????? (FDA)?? ?????????? ??? ?????? ?????? ???????? ???? ????? ??? ???? ???" ??? ??????? ??????? ??????, ?????? ??????? ?????? ??? ????????????? ??? ?????? ???? ? ?????????? ????????? ??????? ???? ???. 1989?? ????? ??????? ????? (FDA)?? ???? ???????? ?????? ??? ???????? ?????? ???? ?????? ??????? ??? ?? ?????? ???? ?????? ????? ????? ??? ???. ???, ???? ????????? ?????? ?????? ?????? ????? ???? ????? (FDA)?? ?????? ?????? ?????? ?????? ??? ??? ??????? ?? ??????? ????. ????????? ????? ??????? ????????????????? ??? ???????????? ??? ????????? ?????? ??????? ?????? ?????? ???? ????? (FDA)?? ??????? ???? ????????? ?????? ??????? ????? ?????? ?????? ??? ????????? ? ????? ??? ???? ???. ??????, 1989??? ????? (FDA)? 11, ??? ??? ???? 13 ?????????? ???????? ???? ???? ?????. ????????? ?????? ???? ??? ??? ???? ???? ????? ????. 1990?? ??????? ????????? ??????? ??.??. ?????????? ???? ???????? ?????? ??????????? ???? ???? ????? ?????? ?????? ??????? ????? ?????????????? ????? ??????? ????????? ??? ???? ?????. [??]

??? ? ??????? ???? [ ?????? ??? ]

??? ? ??????? (?????) (OTC) ???? ???? ??? ???? ?? ???????? ???????, ?? ????? ??????? ???????????????? ???? ???? ???. ????? (FDA) ???? ?????????????? ???? 800 ????????????????? ???? ??. ? ?????????????????? ????? ???? ?????? ????? 1,00,000 ????? ??? ???????? ????? ??????? ??? ??. ????????? ?????????????? ???? ????? ??????? ???????? ???? ????? ??? ??????????????? ??? ??????? ????? ???? ?? ????? ???? ????? ???????? ??. [??]

???, ????? ??? ?????? ???? ????????? ??? ????????????? [ ?????? ??? ]

? ?????? ??? ??????????? ?????????? ???? ?????? ????? (FDA)?? ???? ??, ?? ????? ????????? ????? ?????? ?????? ??????? ??? ??????????? ????????? ?????? ???????? ?????? ??. [??] ????? ???? ??? ???? ??????? ????????, ??? (???), ?????????, ??? ??? ?????? ???? ???????? ??? ??? ????????? ?????????? ?????? ??? ??. ??? ???????????? ?? ?????? ???? ???????? ?????? ?????? ??????? ???????? ?????????????? ???? ???? ??? ??. ?????????? ??????? ?????????? ?????? ????? ?????? ??? ????????? ??????? 1902 ?????????? ???????? ????? ????? ??????? ??? ??? ??? ????? ??????? 1944 ????? ?????? ???? ??????? ????? ???? ???. ? ??????? ????-???? ????? ???, ???? ???? ????????? ??? ?? ???? ????????? ?????????? ???? ??? ??. ????? ???????? ?? ?????? ????? ? ?????? ??? ? ????? ???????????? ?? ????? ???? ??? ???? ??? ?????? 1972??? ? ???? ????? (FDA)??? ???????? ??????? ???.

????? ??? ?????? ???????? ???? ?????? [ ?????? ??? ]

? ?????? ??? ???????? ???? ??????????? ????? (????????) (CDRH)? ????? (FDA)?? ???? ??, ?? ???? ????? ???????? ????? ???????? ?????? ?????? ??????? ?????? ??, ???? ?? ????????? ???????, ??????? ??? ?????? ?? ?????? ???? ??. [??] ????? ??????? ???????? ???? ???? ?? ?????? ??????? ??? ??, ???? ????? ???? ????????? ??????? ????????????? ?????? ????????? ???? ???? ??????? ?????? ??? ??. ? ?????? ???????? (CDRH) ?????? ???????? ?????????????? ?????? ???? ???? ???-?????? ???????? ????? ??????? ?? ????? ??. ???????? ???, ??????? ????? ?????????? ??????????, ???????? ??????, ?????????? ???, ?????? ??? ??? ???? ???????? ????? ???????? (CDRH)?? ????? ??????? ?????? ??.


???????? (CDRH) ????? ??????? ?????????? ???????? ?? ?????? ?????? ??????? ??????? ??????? ????????, ???????? ??????? ????? ???????? ????????? ?????? ????????? ?????? ?? ?? ???? ???? ?????? ??????, ????? ??????? ?????????? ???????? ????? ?????? ???? ???????? ?? ?????? ?????????? ???? ??? ?????? ???? ?????? ????? ????? ??. ???????? (CDRH) ???????? ????????? ????? ??????? ???????? ??? ??.

??????? ???????? (???????????) [ ?????? ??? ]

????????????? ????? ?????? ??? ??? ????? ???? ??????? ?????????? ?????? ??? ??. ????? (FDA)?? ? ???? ????? ?????????? ?? ????? ??? ??. ??????? ?????????? ???????? ???? ??????????????? ? ?????? ???, ?? ???? ????? ?? ??? (??? ?????????????? ?????? ???? ????? ???, ?? ??? ???? ????? (FDA) ?????? ????? ???????? ?????? ???? ???? ???. ?????, ?????????? ?????? ????????? ?????????? ???????? ???????? ??? ??????? ?????? ????? (FDA)?? ?????? ???? ?????? ??. ??????????? ????????? ??????? ????? (FDA) ?????? ?????????? ??? ??, ??? ???? ???????? ??? ?????? ?? ?? ??? ???? ??????? ???????? ??? ?? ?????? ?????? ??? ???? ?????? ??.

????????? ????????? [ ?????? ??? ]

????????? ?????????? ???????????? ????? ???? ??????? ???????? ??????????? ????????? ???????? ??, ????? ??????? ??? ??? ???????? ??? ???, ???? ????????? ????? (FDA) ?? ????? ??????????? ??? ??? ??, ????? ????????? ?????????? ????? ?????? ??????? ???? ?????? ?? ???????? ????? ????? ???. ??????????? ???????? ?? ???? ???, ?? ??????? ???? ??? ?????? ???? ????? ??. ????????? ????????????????? ????????? ???????? ?? ????????????????? ??????? ???????? ????? ???????????? ???? ??????? ??????? ?????? ???? ??, ????? ????? ???? ?????? ????? ??? ????. ?????? ?????? 1,200 ????????????????? ??????? ??? ?? ??? ?????? ?????????????? ?? ???????? ??????? ????? ??? ??, ????? ???????? ???????? ?????? ???????? ??????? ?????? ??? ????? ?? ??????????? ?????? ???, ??? ???? ???????? ?????? ????? ????? ???? ?? ???? “??????"?? ??????? ?? ?????? ???????? ?? ???. [??]

?????????? ????????? [ ?????? ??? ]

? ?????? ??? ???????? ??????? (??????) (CVM) ? ????? (FDA)?? ???? ??, ?? ????? ????? ???????? ??????? ??????? ??? ????? ??????? ????????? ????? ?????, ???????? ????? ??? ???? ??? ??? ???? ??. ?????? ????????? ????? ??? ?? ?????? ??? ??????, ?? ???????? ???????? ??????? ???????????? ?? ?????????? ?????? ??. ?????? ??????????? ????? ????? ???????? ?????? ?????? ????? ???? ?????? ???? ???????? ? ??? ????? ????? ???? ??. ?????????? ?????? ???????????? ???????????? ?????? ???? ?? ?????? ???????? ????? (FDA)?? ????-???? ?????? ?? ?????? ??. ?? ?????? ???? ??? ????? ????? ??????? ?????? ??? ??.

?????? [ ?????? ??? ]

??????? ?????? [ ?????? ??? ]

????? ??? ???? ???? ????????????? ??? [ ?????? ??? ]

20?? ??? ???? ??????? ????? ???????? ????? ??? ????? ???? ??? ??????? ????? ????? ?????? ????? ????? ???, ????? ???????? 1813?? ??????? ??? ???????? ???. ?????? ?????? ????????????? ?????? ????? ????????? ??? ????? ??? ??????????? ????????? ???? ????? ???? ?????? ????? ????????? ???? ???? ???? ????? ????? ????? ???. ??????? ?????? 19?? ????? ???????????? ??? ??????? ??????????? ?????? ?? ?????????? (?????? ?????? ?? ??????????)????? ??? ??? ??. ???? 1883??? ????? ????????????? ????? ?????? ????? ?????? ????????? ?????? ???? ???? ??????? ??????? ??????? ????? ??????? ??? ?????? ?????? ??? ????????????? ???? ?????? ??? ?????? ????. ??? ??? ????????? ????? ?????? ???? ???? ???? ??????? 1887?? 1902 ??????? ????? ???? ??? ????????? ????? ???? ?? ????? ?? ????????? ????? ??????? ???????? ?????. ????? ? ????????? ????? ????? ??? ???? ??????? ?? ?????? ????? ???? ?????? ????????? ??? ?????????? ???? ????????????? ???? ????????? ?????? ???? ????? ?????? ??? ????????? ?????? ????? ??? ??? ???? ???? ??????? ?? ??? ????????? ????? ???? ????? ?? ???????? ??????? ?????. ?????? ????? ??? ???? ?? ??? ????? ??????? ???????? ???? ??????????? ?????????? ?????????? ?????? ????? ????? ????? ???? ???? ???? ????? ????? ??? ??? ???????? ??? ??????? ?????? ???????? ???? ???????? ????? ?????? ???? ?????? ??? ??? ???. [??] 1902??? ???? ?? ????? ??? ????? ????????? ?????????? ???????????? ??? ????????? ????? ??? ? ????? ?????? ??????? ??? ??????? ?????????? ??????? ??? ?????? ????? ???.

1906 ??? ???? ???? ??? ??? ????? (FDA)?? ???? [ ?????? ??? ]

??? 1906??? ?????? ??????? ????????? ??? ???? ???? ??? ?? ????????? ????? ???. ? ??????? ????? ????? ????? ?????? ????????? ?????? ????? ?? "???? ???" ????? ?? ????? ??. ? ????? "???????????" ???? ??? ???? ????? ???????? ???????? ?????? ?? ???????? ???? ??. ?????? ? ???????? ??? ???????????? ??????? ??????, "???? ???? ????? ?????"?? ??????? ???? ??? ??????, "????????? ???? ????????" ????? ???? ?????? ???? "????, ????????? ???? ?????" ??????? ????? ???? ????? ?? ?????????? ?? ?????? ??????? ????? ???. ? ????? ???? ????? ?????? ???? ??? ????????? ???????? ??????? ???? ??????? "????????, ??????? ???? ????" ???? ?? ????????? ??????? ? ??? ???? ???????? ???????? ???????????? ???? ????? ??????????? ??? ??????? ? ??? ???? "???????????" ????? ???????? ??????? ???? ??? ???? ??? ??. ? ????? ????? ?????? ??? ????? "???? ??????????" ?? ?? ???????? ???? ??. [??] ? ???????? "?????????????" ???? "???? ??????????" ???? ????? ?????? ??? ????? ???????? ???????? ?????? ??????? ?????? ?? ??????????(61)?? ???????? ??? ???. [??]

????? ? ??? ????????? ???????? ????? ????? ????????? ????? ??????? ?????? ???? ???????? ???? ?????? ?????? ???????? ??? ???, ????? ?????????? ???????? ??????? ??????? ??????? ?????? ?????????? ????? ???? ????????? ???? ?? ??? ?????? ????? 1907 ??? 1908??? ???????? ????? ?? ??? ???? ???? ?????????? ??? ????? ????? ?? ???????? ?????????? ???????????? ???? ??????? ???. ???? 1911??? ???????? ?????? ???? ????? ?? 1906?? ????? ??????????? ??????????? ???? ???? ?? ???? ???? ???. [??] ??????? 1912?? ????????? ??????? "???? ??????????"?? ?????????? ???????? "??????? ???? ??????????? ???"?? "???? ??? ??????" ?????? ????? ??????? ?????. ????, ?????? ?????? ? ???????? ??????????? ??????????? ??????? ???? ??????, ???? ??????? ???????? ????? ?????? ???? ???? ????????? ??????? ???. [??] 1927??? ?????? ?? ???????????? ????????? ???????? ??? ??????? ???? ????? ??????, ??? ??? ???????? ?????? ???? ??????? ?????? ??????? ??? ???. ???? ???? ??? ? ????? ????? ????? ????? ??? ??? ?????? ????? (????? (FDA)) ??????? ?????? ????. [??]

1938 ???, ????, ???? ????????? ???? [ ?????? ??? ]

1930?? ?????? ????????, ?????? ??????? ??????? ??? ????????? ?????????? 1906?? ????? ???? ??????? ????? ??????? ????? ????????? ???? ???????? ?????????? ???? ????? ????? ????? ????????? ??????? ??? ???? ?????? ?????? ????????? ??????. ? ??????????? ??????????? ????, ?????? ???? ??? ???? ??????????? ??? ????????? ??? ??????? ???? ???????? ???????? ?????? ??? ??. ??????? ????? ????? ???? ???? ???? ??????? ??????? ???? ?? ???? ?????, ????? 1937??? ???????? ????????????? ???????? ?? ?????? ???????? ???? ????????? ? ????? ?????? ????? ???. ? ??????????? ??????? ???? ??????? ????? ?????? ???????? ??????? ??? ????????? ????? ??? 100?? ??? ??????? ??? ??????? ???. ????? (FDA) ???? ???????????? ???????? ????? ? ????????? ???? ??? ??? ?????. ?????????? ???????? ????????? ?????? ??? ????? ???? ??? ?????? ???????? ???????????????? ????????? ?????????? ????? ??? ???.

?????? ?????????? ?????? ????????? ??? 24, 1938?? ??? ??? ???, ????, ???? ????????? ???? (FD&C ????) ?? ????????? ????? ???. ??? ?????? ??? ? ??? ?????? ???????? ????-??????? ??????? ??????? ??????? ??? ????? ??????? ?? ???????? ???? ????? ?? ???????? ?????? ???? ?? ????? ????????????? ???????? ????????? ????? ?????. ? ?????? ???????? ???? ???????? ????? ??? ????????? ?????? ?? ????? ????? ??????? ???? ??? ????????? ????? ??????? ????? ??? ????????? ??? ??????????? ??????? ?? ????? ??????????? ??????? ???? ???????? ?????. ????? ???????? ? ???????? ???? ?????? ??????? ????? ???? ???? ????? (FDA) ????????? ???????? ?????? ????? ??????? ???????? ?? ????? ? ?????? ??. [??]

1938 ??? ???? ???? ??? ????? ???????? ?????? [ ?????? ??? ]

???? ???? ?? ??????? ????????? ??????? 1938-1958 [ ?????? ??? ]

1938?? ????? ???? ??? ??? ???? ? ????? (FDA)? ?????? ???? ????? ????? ????????????? ???????? ???? ????? ???? ????? ????? ??? ???????? ??? ?????? ??? "??????????????-?????" ????? ????????? 1951?? ?????-??????? ??????????? ?????? ???????? ???????? ??????? ??????? ???. [??] 1938?? ????? (FDA)????? ????? ???? ????? ???????????? ????-??????? ??????? ???????? ?????? ?????? ?????????? ??????????? ??? ????????? ??????????? ???? ???????? ????????? ?????? ?????? ???? ???? ??????? ??????? ???????. [??] ????? (FDA)? ????? ???? ???? ??????????? ????? ???? ???? ???? ??? ???????? ???? ???? ??? ??????? ????? ??????? ??? ?????? ??? ???????? ??? ????????? ??. ??. ???????? ??????? (1950)?? ?????? ???????? ????????? ????? ?? ?????? ??? ?????? ???????? ?????? ???? ????? (FDA)?? ???????? ??? ?? ??????. ? ??????? ?????? ??????? ???? ?? 1938?? "???? ??????????? ????"?? ???????????? ??? ?????????? ????? ????? ????????? ????? ??????? ??? ?????? ????? ??? ???? ????. ??????? ? ?????? ???? ?????????? ?????? ????????? ???? ???? ??? ??????? ????? (FDA)?? ?????? ???????? ?? ?????? ???. [??] ??????? ?????? ????? (FDA)?? ???????????? ?????????? ????? ????????????? ??? ????????????????? ???????? ??? ??, ????? ?????? 1938 ??? 1962 ??????? 13,000 ??? ?????? ?? ??????? ??? ??? ??. ? ????? ????????? ??????????? ???? ????????? ????????? ?? ?????? ??? ?????? ???? ??????????? ??????? ???? ?????? ?? ??? ?? ??? ? ??? ??????? ????? (FDA) ????????? ??? ????? ?????? ????? ????????? ??????? ??????? ??? ??. [??]

????? ??????? ?????? ???????????? ???????: 1959-1985 [ ?????? ??? ]

1959??? ???????????? ??????? ????? ???? ????? ??? ???????? ?????? ????? ??????? ?????? ???????? ??????????? ???? ?????? ?????????????? ???????? ??????? ???? ??????? ??? ??????? ??? ?????? ????. ???? ???? ?????? ????? ??? ??? ??? ???? ????? (FDA)?? ???????? ??????? ???? ??? ????? ??????? ???? ?? ???. ?????????? ???????? ??? ? ????????? ????? ???. ? ??????????? ????? ???????? ??????? ???????? ?????????? ??????? ???? ?????? ???????? ?????? ???? ?????? ? ??? ???? ??? ????? ??????? ???? ????? ???. ????? (FDA) ??????? ????????? ?????? ???????? ??????? ????? ?????????? ???????????? ??????? ?????? ???. ?? ?? ??? ?????????? "???????? ?????????????" ?????? ??????? ????? "????????? ?????" ??????? ????????? ????? ???. ?? ???? ?? ??????? ????? (FDA)?? ????? ???? ? ????. ????? (FDA)?? ??????? ??????? ???? ????? ?????? ???? ???? ???? ?????????? ????????? ?????? ?????????? ?????????? ?????? ????? ???. [??]

1962??? ???? ???? ?? ??????? ??????-????? ??????? ????? (FDA) ????? ???????? "???????" ??? ???. [??] ????????? ?????? ?? ??? ?? ???? ??? ????? ???????? ??????? ????? ???? ????? ??????????? ???? ????????? ?????? ???? ????? ?????? ????. ? ?????? ????? ????? ????? ???? ???????? ?????? ?????? ??????? ?????? ???? ?? ??????????? ??? ?. ?????? ????? (FDA)?? ?????? ????????? ???? ?????? ????????? ??? ??. 1938?? 1962?? ????? ????? ????? ?????? ??????????? ????? ????? (FDA)?? ????????? ???? ?? ??? ??? ?????? ???? ????????? ???? ?? ?????? ???. 1962?? ????????? ???? ????????? ???????? ?????? ????? ?? ??, ??? ??????? ????? ??????? ????? ???? ????? "???????" ???? "??????" ????? ????? ???? ????? ??. ?????? ??????? ????? ??????? ??????? ???????? ???? ????? ??? ??????? ??? ??????? ????? ???? ?????? ????? ??????? ??? ???.

? ???????? ????? ????? ??????? ????? ?????? ?????? ????? ??? ???. [??] 1970?? ??????? ??????? ??????? ????????? ????? 14????? 13 ??? ?????????? ???? ????? ???? ??????? ?????? ???. [??]

1984 ???? ?????? ?????????? ???? ?????? ???? ?????????? ???? ?????? ??????? ??? ???? ???? ???? ?????? ????????? ????? ?????? ?? ???. ?? ???? ????? ?????????? ??? ???? "???-???????? ????" ????? ?????? ???. ? ??????? ???? 1962?? ?????? ?????? ???? ????? ??? ????? ??? ??????? ?????? ????? ??????? ????????? ????????? ???. (?????? ????? ????? (FDA) ?????? ????? ?? ?????? ???????? ??? ???? ???????? ??????? ?????? ???? ?????????? ???? ?????? ??? ?????? ??). 1962?? ?????? ?????? ???? ????? ??? ??????? ???????? ?????????? ????? ????????? ???????? ??????? ????? ????? ??? ??? ??????? ????? ???? ???????? ?????? ????. "????????" ??? ?????????? ?????? ?????? ?????????????? ??????? ????? ???????? ???. ???? ????, ????? ????? ????? ?????? ????? ?????? ??? ??????????? ?????? ??? ???????? ??????? ??? ?????? ????. "????????" ????????? ?????? ??? ?????????? ???????? ??????? ????? ????? ?????? ????????? ???????? ?????? ????????? ??? ???? ??????? ??????? ?????? ??????? ???. ???-???????? ?????? ???? ???????? ??? ?????? ??? ???????? ????? ?????? ???????? ??? ?????? ?????? ??????? ????? ?????? ??? ???? ???????? ???. ??? ??? ???? ??? ?? ??? ??? ?????????? ??? ????????? ????? ?????? ????? ????? ?????? ????? ????.

? ?????? ??? ????? ?????? ?????????????? ?????? ??????? ????? ??? ??? ???????? ????????? ??? ???? ? ?????????? ????? (FDA)?? ?????? ????????? ???? ???? ???. ?????? ??? ???????? ???? ? ?????? ??? ?????? ???????? ???????????? ???? ???? ????????? (??????)(ANDA) ??? ??? ???. ????? ?????? ??? ????????? ????? ????? ? ????? ??????? ?????? ???? ?? ?????? ?????? ????????? ??? ???? ? ?????? ????, ????? ?????, ?????? ??????, ????? ??? ???????????????? ???????? ("?????????") ????? ??. ? ??????? ?????? ?????? ??? ?????? ??? ?????? ????? ??? ??. [??]

??????? ?????? ????? (FDA)??? ?????? [ ?????? ??? ]

????? (AIDS)?? ????????? ??????? ?????????? ????? ?????? ???? ?????? ??????????? ????? ????? ????? ?????? ??????? ???. 1980??? ????? ????? ??? ?????? ????-?? ??? ???? ?????? (HIV) ???????? ???????? ??????? ????? (FDA) ?? ?????? ??? ????????? ??? ?? ????? ???? ?????? ?????? ?????? ??????? ???????? ????? ?????? ???? ??????. ? ??????? ????? (FDA)?? ???????? ??????????? ??????? 11, 1988 ????? ????? ????? ????????? ??????? ????, ????? 180 ????? ?????? ?? ???. [??] ????? 1990??? ????? ?????? ??????? ?????? ??????? ?????? ?? ?????? ??? ??. ??? ????????? ????? ????? ???? ?????? ??? ????? ?????? ?????? ?????? ??? ????? (??????????)??? ???? ??????? ????? ?? ????? ????? ????? ??? ??????? ??? ??. [??]

????? (FDA)? ? ???????? ????? ???????????? ?????? ???? ?????? ????? ???????? ????????? ???? ?????? ???? ??? ????? ????? ?????? ??? ????? ???? ???????? ??????? ??????? ?????? ???? ?????? ????? ?????? ??? ?????? ?????? ????? ????? ???????. [??] ? ??? ???????? ?? ????? ???, “?????? ??????????” (“?????? ??????”) ???? “?????????? ??????” (“????? ??????”). ? ?????? ????? ???? ??? ?????? ????????? (???? ??????? ?????????? ???? ?? ???????? ?????????) ???????????? ???? ?? ????? ???????, ???? ??? ????? ?????? ???? ?????? ?????? ????? ????? ???????? ???? ??? ???? ?????? ?????? ??????? ????? ??? ??, ????? ??????? ??? ?????? ?????? ????? ????? ???. ???? ??? ???? ???, “?????? ????? ??????” (“?????? ?? ????). ? ?????? ????? ????? ??????? ?????????? ???????? (???????? ????????)??? ??? ? ?? ????? ???????? ??? ????????? ??? ?????? ?????? ?????? ? ???? ?????? ??? ??? ?? ??????? ?????? ???? ???? ????? ??????? ??? ???. “?????? ?????”?? ??????, ?????? ????? ???? ??????? ??? ???. ???? ????? ??????? ???????? 1992??? ??? ??????? ??????? ?????? ??? ???? ????????? ????????? ???. [??]

??????(HIV)/????? (AIDS)?? ?????? ???? ?????? ?????? ??????? ???? ???? ???? ?????? ???????? ?????? ? ????? ??????? ??? ???. ?????? ?????, ????? ?????? (HIV) ???, ?????? (AZT), ?????? “?????????? ??????” 1985??? ????? ??????? ??? ??? ??? ???? ?????? ????? ?? ???? ??? 1987??? ??????? ??? ???. [??] ?????? (HIV)?? ?????? ?????? ????? ???? ???????? ???? ?????? ???? ????? ?????? ?????? ????? ?????? ???????? ?????????? ?????? ??????? ??? ???. [ ?????? ??? ]

????? (FDA) ??????? ???? ?????? [ ?????? ??? ]

?? ?????????? ????? ??????? ????? (FDA) ?????? ????? ? ??????? ????? ?????? ??????? ????????? ????? ??????? ??. ????????? ????? ? ????????? ?????????? ???????? ??????? ??? ??. ???? ????? ????????? ???????? ????? ???? ????????? ??????? ?????? ?????? ??????? ????? ??? ???? ???? ???, ???? ???? ??????, ????? ?????? ??? ????????? ????????? ?????? ????? ????????? ????????? ????? ??.

??????????? ????? ????? 1970??? ???????? ??????????? 27 ?????? ?????? ???? ????? ???. ? ??? ???????? ?????? ???? ???????? ?????? ???, ????? ? ???? ??????? ??? ?????? ??? ???????? ?????? ????????? ?????????? ? ??? ??????? ? ??????? ??????. [??] [??] ????????? ??????? ????? ? ????? ????????? ???????? ???????? ?????? ? ????? ??????? ??? ????? ?????? ???????? ? ???. ???????? ?????? ?? ??????? ?????? ??? ????????? ????? ?? ???????? ????????? ? ????? ??? ? ????????? ? ???? ???, ????? ?? ?????? ??, ??????? ???????? ???? ????? ????????? ????? ???????? ????? ???. ?? ??, ?????? ???? 1980?? ???????? ? ??? ?????? ???? ????, ???????????? ??????? ??????? ????? (FDA) ?????? ??????? ??? ????? 2000??? ????? ???? ????? ?????? ??. [??]

???? ????? 1990 ??? 2000??? ???????? ?????? ????????? ?????? ???. ?????????? 1979??? ???????? ???? ?????? ?? ????? ???? ????? ???? ????, 1996??? ??????????????? ? ????? ??? ????????? ??? ??? ????. ????? ?????? ?????? ? ????? ????? ?????? ?????? ????????? ????????? ??????? ????? ????????????? ???? ????? ???????? ??????? ????? ??????, ???? ??????? ?????????????? ???? ????????? ??? ?? ??. ?????? ???? ??????? ????????? 2009 ???? ???? ?????? ??? ????????? ?????? ??? ?? ?????????? ??, ????? ?? ?????? ??? ?? ????? ???.

????????? ????? ??? ??????????? ?????? [ ?????? ??? ]

???????? ??? ????????? [ ?????? ??? ]

???????? ??? ????????? ???????? ????-??-?? ?? ??? ????? ???? ? ?????????? ?????? ?????? ????????? ???????? ??????? ???? ??? ???? ??? ?????? ???? ????? (FDA)?? ?? ?????? ??. ? ???????? ?????? ? ????? (FDA) ?????? ??????? ???????? ????????? ??, ????????? ??? ?? ??? ?????? ??????? ??????? ??? ??. ‘???????/??????????? ??????? ???? ??????????? ?? ?? ???????? ??? ?? ???? ?????? ??????????’ ?????? ??????? ???????? ????????? ???? ? ? ?????? ????? 2004??? ? ??? ??????? ????? ???. [??] ???????? ????-??-?? ?? ??? ????? ???? .

????? ??? ?????? ???? ???????? ???????? ?????? [ ?????? ??? ]

??????? ??????? ??. ??? ????????? 2006??? ?? ????? ????? ????? ????? ??? ?????? ???? ?? ????? (FDA)?? ???????? ?????? ????????? ??????? ??? ???. ??????? ????????? ???? ??? ?? ???? ????????? ??????? “????????? ??????????” (??????????? ?????) ??????? ???????? ????? ???? ????? ????????? ??????? ????? ?? ?????? ?????? ????? (FDA)? ??????? ????? ? ????. [??] ? ??? ?? 2006??? ???????? ??????? ???? ?????? ???, ????? ????? 2007??? ????? ????????????? ? ???????? ???? ????? ?????? ???. ?????? ???????? ?????? ? ??? ?????????? ???????? ??? ?????? ?????? ???? ????? ??? ?????? ???? ????????? ????????? ???????? ? ? ??????.

????? ??? ????? ?????? ?? ?????? [ ?????? ??? ]

???-????????? (???????? ??????) ?????-???????????? (????? ??????) ???, ??????? (Vioxx)?? ????????? ???? ???????? ????? ????????? ?????? ????? ????? (FDA)??? ???? ???? ??? ??????? ?????? ??????? ???????? ??? ???? ??? ??????? ????? ?????? ???? ???. ? ????? ????? ?????????? ????????? ???? ???????? ????? ??? ?????? ????? ????? ??. ??????? (Vioxx)?? 1999??? ????? (FDA) ?????? ????? ??????? ??? ??? ??? ???????? ?? ???????? ?????? ????????????? ?????? ?????? ?????? ???? ? ???????? ??? ????????? (NSAIDs) ????? ??? ???????? ???????? ??? ???. ?? ??, ?????????? ???????? ??? ????? ????????? ??????? ?????? ?????? ??, ??????? (Vioxx)?? ????? ?????? ????????? ???????? ????????? ???? ???? ?? ????? ????????? ??? ?????? ???? ??? ??? ??.? ?????? 2004??? ?????? (APPROVe) ?????????? ??????? ?????? ??????????? ???? ??????????? ??? ???. [??] ???????? ????????? ???????? ????? ????? ??? ?????? ???????? ????????? ???? ????????? ? ????? ???? ????? ???? ???. ??? ?????? ????????? ??????? ????????? ????? ???? ???? ?? ????????? ???????????? ????? ???????? ???????? ????? ????????? ????? ???? ???? ???? ??? ???? ????? ???????? ??????? (Vioxx)??? ? ?????? ??????? ??. ??????? (Vioxx)?? ????????? ???? ????? ???? ??? ????? ??????, ????? ???????, ??????????? ??????, ???????????? ??? ????? (FDA)?? ???????? [??] ?????? ????? (FDA)?? ?????????? ????????? ??? ?????? ????? ?????????? ???????? ????????????? ???????? ???????? ????? ????? ????????? ?? ?????? ??????? ??????.

2006??? ?????? ???????????? ???????? ???????????? ?? ??????? ?????? ??.??.??? ?????????????? ??????? ???????? ??????? ??? ?????? ???? ????? ????? ???? ???? ?? ??????? ??????? ??????? ???. ? ???????? 16 ????????? ????, ????? ?????????? ???-????? ?????? (???????? ????????????? ??????), ???????????, ????????????? (?????????????????), ?????, ????????? ???? (?????? ??????), ????? ?????? (?????? ?????) ??? ?????? ?????? ??????????? ??????? ?????? ??????????????, ???????? ??? ?????? ???? ????????? ??????? ??? ???????? ?????????? ?? ?????? ??? ??. ? ??????? ??????? ??????? ????? ????????? ??????? ?????? ????? (FDA)?? ??????? ??????????? ???? ???? ???? ???. ??? ????? ?????? ????? (FDA)??? ???????????, ??????? ???? ??? ????????? ????????? ????? ?????? ???????? ?????? ???. [??] [??] ? ???????? ??????? ??????? ????????? 4 (PDUFA IV)??? ??????? ?????????? ????? ??????? ????? ????, ???? 2007??? ???????? ?????? ?????? ????. [??]

????? ?????? ?????? ??????? [ ?????? ??? ]

1990?? ??? ?????? ???????? ?????????? ??????? ??????? ???? ???? ????????? ????? 20 ??? ??????? ??????? ? ??????? ??? ??? ???? ??????? ???? ??????? ????? ????. ? ????? ?????? ??? ?????? ?????? ?? ??? ???? ??????? ??????? ???????????? ?????????, ?? ?????? ?????? ?? ??? ??? ????? ????????? ???? ??? ??? ???, ?????? ?????? ??????? (????????????????) ?????? ????? ?????? ??????? ???. ????? ?????? ????? ???????? ????????? ??????? ????? ??? ??. ??? ?????? ?????? ??????? ????? ???? ??? ??????? ?????? ?? ????? ?????????? ? ???????? ???????? ??????? ????? ??????. ?????? ?????????? ?????? ??????? ??????? ?????? ????? ???? ???????? ???????? ??? ??. ??? ? ???????? ???????? (?????????? ????????)?? ?????? ???? ?????? ??? ????????? ???????????? ????? ??? ??? ??? ?????? ???????? ???????? ????? ?? ??? ???? ?????? ?????? ???. ??? ?????? ???? ??????? ??????? ??????? ???? ????????? ???? ???-????? (FDA)-????????, “??-????” ???? ??????? ???? ???. ????? ????? ??????, ???????? ?????? ??? ??? ?????? ???????? ????????? ?????? ????? ??? ???? ???????, ???? ??????? ????????? ???????, ????? ??????? ???? ???. [??]

? ???????? ???????? ???????? ?????? ????? (FDA)? 1994??? ????? (FDA) ????? ??? ?? ??????????? ??????? ???? ??????????????? ?????? ?????. ????? ?????????? ??????????? ??????? ?????? ?????? ??? ???, ????? ?? ??????? ??????????? ??????? ??? ????????? ????? ??????? ? ???? ???, ???? ???? ?? ?????? ??? ??. ?? ??, ? ???? ??? ??? ???????? ??????? ??????????? ??? ???????? ???? ???? ?????????? ?????? ?????. 1997??? ????? (FDA)? ???? ???? ?????????????? ????????? ?????? ??????????? ?????? ??????? ????? ?????? ?? ???? ?????????? ????? ???. ?? ??, ? ??? ???? ????? (FDA)?? ??????? ????? ????????? ???? ??????? ????????? ???????? ??????????? ????????? ??????. ?????? ? ????? ???? ??? ??? ??????, ????????? 1997 ????? ??? ??? ?????? ????? (?????) (FDA) ???????? ??????? ????? ??? ??????????? ???? ???? ?????. ????? ?????????????? ?????????? ??????????? ?????????? ????? ???? ??? ??????? ????? ??? ???? ?? ? ????? ??????? ?????? ???? ??????? ???. ? ????????? ???? ?????? ???? ????? 2002 ????? ???????????????? ??? ???????? ???? ??????? ?????. ????? ????? (FDA) ??????????? ?????? ??????? ???? ???????? ????????? ??????? ???????? ?????? ??????? ????? ??, ?? ?? ? ??????? ?????? (NIH)?? ???????? ?????????? ???????? ?????? ??????? ??? ??. ?????????, 2003??? ??????????? ?????? ??????? ???????, ????????? ????? (FDA)?? ?? ??????????? ??? ????? ??????? ????? ???????? ?????? ???? ?? “?????? ????” ????? ?????? ???? ???? ??????? ????????? ??????????? ????? ???????? ???? ???? ???? ?????? ????? ??? ?? ??? ???? ???????? ?????? ?? ?????? ??. [??]

?????? ??????????? ???? ????? [ ?????? ??? ]

1990?? ????? ??????, ????????? ???? ??? ???? ????????? ?????? ???? ??? ??? ??? ???? ??????? ?????? ???????????? ??? ??? ??, ???? ????? ?????? ??? ??????????? ?????????? ???? ?????? ?????? ??????? ??? ??. ? ???????? ????????? ??? ?????? ????? ??? ??, ?????? ?????, ?????? ?????? ??? ?????????? ?? ?????? ???????? ????? $55,000 ????? ??? ??, ?????? ??????? ???????????? ?????? ?????? ??? ?????????? ?? ?????? ???????? ????? $200,000 ????? ??? ?? ??? ?? ??????? ??????? ?????? ??? ?????? ??????? ???? ??? ??. ?????????????? ????, ???????? ?????? ??? ???, ??? ? ????? ???? ???? ???????? ?????? ??? ?????? ??? ????? ??? ??? ???????????? ???????? ??? ??????? ???? ????? ?????? ?????? ???? ??????? ?????? ??????? ??????? ??? ??. ? ???????? ????????? ?????, ??? ????? ?????????????? ???? ???? ??????? ????? ???????? ?????? ????? 1984 ???-???????? ??????? ????????????? ??????????? ???? ???? ????????? (??????) (ANDA) ???????????? ?????? ??????? ????? ?????. ????????? 2007??? ??????? ????????????? ??????? ???? ?? ?????? (ANDA) ????????? ???? ???? ? ? ???????? ???? ???? ??????? (?????? ? ???????) ??? ??????? ?????? ????, ????? ?? ???? ?? ?????? ?????. [??]

????-??????? (??????) [ ?????? ??? ]

?????????? ?? ???: Obama calls food safety system a 'hazard to public health'

??????? ????????? ?????? ??? ????? ??? ????? ??????????? ???? ????? ??? ????? (FDA) ????????? ?????? ?? ??? ??. [??] ???? ??????? ?????? ?????? ??? ???-?????? ??????? ?????? ????? (FDA)?? ?????? ??? ?????????? ????????????? ??????? ??????? ??? ??. ??????, ?????????????, ????????? ??????? ??? ?????????????? ?????? ?????? ????? (FDA) ??????? ??? ??????? ????????? ??? ?? ??? ????? (FDA)?? ???? ?? ??????? ??? ??. $1.8 ?????? (18 ??? ????) 2006??? ??.??.??? ?????????????? ????? ????? ???????????? ?? ?????????? ????????? ??????? ??????? ?????? ????????? ??????? ?????? ????? (FDA)?? ??????? ??????????? ???? ???? ???? ???. ??? ????? ?????? ????? (FDA)??? ???????????, ??????? ???? ??? ????????? ????????? ????? ?????? ???????? ?????? ???. [??] [??]

?? ????? (FDA) ??????????? ?? ????? ???? ?????? (??????????? ??????) ????? ??????? ??????? ??????? ????? ???????? ??????? ????? ???????? ??????? ????????? ??????? ???? ???? ????? ???? ????? ???? ???? ??????????????? (??????????) ?????? ??????? ????? ?????? ?????? ???? ???????? ????. ????? ????? (FDA)??? ????? “????? ????? (FDA) ???????? (???????) ?????? ?????? ??? ????? ????? ???????? ??? ???? ??????? ?????? ??????? ?????” ???? ?????? ????? ?????? ????. ?????? ???? ? ? ???????? ????? 2006?? ????????? [??] ?? ?????? ??????? ??? ???. [??]

????? (FDA)?? ?????? ???????? ?????? ???????? ????? ????? ?????? ??????????? ???????? ??????????? ?????? ?? ?? ????????????? ?????? ???????? ??????? ??????? ?????? ???????? ?????????? ??????? ??. ??????????? ???? ???????? ????? (FDA)?? ???? ????????? ??? ???? ??? ???????? ??????, ????????? ???? ???? ?????, ??? ???????????????? ??????????? ?????? ?????? ??? ??. ?????? ??????? ?????????????? ???? ??? ?? ??, ??? ??? ????? ???? ??? ???????????? ????? ???????????? ??????? ???????? ???? ????? ???? ???? ????? (FDA) ????? ???? ???? ???. [??]

?? ??, ?????? ? ???? ??????? ??? ?? ?? ????????????? ???? ?????? ?????? ????? ????????? ??????????? ???????? ?? ??, ????, ?????? ?????????? ?????? ?????? ??? ??. ???????????? ?????? ?????? ????? ?? ??, “??????? ?????????? ???????? ??, ??? ????? ?????? ?????? ???????? ??????????? ???????.” ????? ???? ?? ??,“?????? ???? ????-?????????? ??? ?????? ???? ? ???.” ??? ????????????? ?? ????? (FDA) ????? ??????? ???????? ??? ??, “?? ?? ???????? ??????? ???????? ??????? ??. ?????? ???????, ??? ? ????? ???? ??? ?? ??, ????-???????? ?????? ??? ????? ?????? ???? ???.” ????, ???????? ???? ????? ?????? ?????? ??? ??????? ???????? ???? ??????? ??????????????? ?????? ????? ???? ??. [??]

????? ????????? ????? [ ?????? ??? ]

????????? 2004??? ??????????? ?????????? 510(k) 033391?? ??????? ???? ? ????? (FDA) ??. ??????? ???????? ????? ??? ???? ?????????? ????? ???? ???? ?? ?????????????? ????? ????? ????? ????? ????? ???? (?????? ???????) ??? ??????? ??? ??????? ????? ?????? ?????? ??? ????. ????? ????? ??? ???? ???? ?????????????? ?????? ?? ?????????????? ????? ????? ????? ??????? ??? ?????????? ???? ?????? ?????? ?????? ????? ????? ?????? ??.

??? 2004??? ????? (FDA)? ???? ?? ????? ?????? ?????? ??????????? (??? - ???)?? ?? ????? ????? ????? ?????? ?????? ?????? ??? ??.

? ?? ??? [ ?????? ??? ]

  • ????? ??? ??? ?????? ????? (?????) (FDA)?? ????
  • ???? ??????? ????? ???????????????
  • ???????? ????????? ??????
  • ??? ??????????????
  • ????? ??? ??? ?????? ????? (?????) (FDA) ?????? ?????, 2007
  • ?????????? ????????? ?? ????????????? ?? ??????? ??????????????? ??? ??????????? ?? ???????????????? ??? ?????? ??? (??????) (ICH)
  • ?????????????? ?????? ???????????
  • ?????? ????? ???????????
  • ????????? ???? ???????? ?????????? ??????????? ?????? (????) (UK)
  • ?????????????? ?????
  • ? ??? ??????? ????? ??????, ????? (FDA)??? ???????
  • ?????? ???
  • ???? ?? ???????? ???????????????
  • ?????????????? ???????? ????

??????? [ ?????? ??? ]

  1. ↑ "FDA Centennial 1906-2006" . US FDA. ??? ????? 2012-08-06 ?? ???????? . ?????? 2008-09-13 .
  2. ↑ "FDA commissioner" . US FDA. ??? ????? 2009-05-27 ?? ???????? . ?????? 2009-05-27 .
  3. ↑ "FDA 2008 ORA Field Activities" (PDF) . USFDA. ??? (PDF) ????? 2009-03-26 ?? ???????? . ?????? 2008-09-13 .
  4. ↑ "FDA's International Posts: Improving the Safety of Imported Food and Medical Products" . USFDA. ??? ????? 2010-08-10 ?? ???????? . ?????? 2010-04-10 .
  5. ↑ ?.? ?.? Gardiner Harris (November 2, 2008). "The Safety Gap" . New York Times Magazine .
  6. ↑ "???? ?? ????? (FDA)? FY 2008 ????" . ??? ????? 2009-05-12 ?? ???????? . ?????? 2010-09-02 .
  7. ↑ "???, ???? ???? ????????? ???? ??? ?????" . ??? ????? 2009-05-12 ?? ???????? . ?????? 2010-09-02 .
  8. ↑ http://www.cfsan.fda.gov/~lrd/cfsan4.html ???????? ????-??-?? ?? ??? ????? ???? ?????? ??? ??? ?????? ???? ??????? ??????????? ??????
  9. ↑ ??????? ?????????? ????? ???? ????????? ??? 1994 ???????? ????-??-?? ?? ??? ????? ???? ??? ???? ????? 5 ????????? 2007.
  10. ↑ [?]  PDF (106 KB) ??? ?? ????? ??????????????? ????? 21
  11. ↑ http://www.dwrf.info/documents/recent_dev_bw_quality.pdf  PDF (217 KB)
  12. ↑ 21 CFR 202: ?????????????? ???? ????????????
  13. ↑ 21 CFR 314.80: ??????????????? ?????????? ?? ?????? ???? ??????????????
  14. ↑ ??????: ? ????? (FDA) ?????? ?????????? ???? ?????? ?????? ?????????? ????????? [?] ???????? ????-??-?? ?? ??? ????? ???? . ????? ??????? 9, 2007
  15. ↑ ??.? ??.? ??.? ??.? ????? ????. " ?????????? ??????? ???? ??????????? - ???????? ??????? - ?????? ???? ????????. " ? ???? ??? ?? ????? - ??????? ???? ?????. 1990. 276-81. ISBN 0-7172-8244-9 .
  16. ↑ "Therapeutic Equivalence of Generic Drugs" . U.S. Food and Drug Administration. 1998. ??? ????? 2009-05-12 ?? ???????? . ?????? 2007-10- 10 . Check date values in: |access-date= ( ??? )
  17. ↑ ????? (FDA) ??????? ????????: ???-??????? ???? ?????????? [?] ???????? ????-??-?? ?? ??? ????? ???? ????? ??????? 9, 2007
  18. ↑ "?????/???????- ??????? ????" . ??? ????? 2009-05-11 ?? ???????? . ?????? 2010-09-02 .
  19. ↑ 2005 report of the CDRH Radiological Health Program Core Group  PDF (90.3 KB)
  20. ↑ Ross G (2006). "A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health". Int. J. Toxicol . 25 (4): 269?77. doi : 10.1080/10915810600746049 . PMID   16815815 .
  21. ↑ ??.? ??.? ??.? ??.? ??.? ??.? ??.? ??.? [?] ???????? ????-??-?? ?? ??? ????? ???? ? ???????? ?? ? ????? (FDA) (FDA).gov ??
  22. ↑ [?] ???????? ????-??-?? ?? ??? ????? ???? ??? ???? ?????? ???? ???? ???????????????? ??? ????
  23. ↑ ?????:Cite court
  24. ↑ ??.? ??.? [?] ???????? ????-??-?? ?? ??? ????? ???? ??????????? ?? ???? ??? ???? ???? ?? ???????? FDA.gov
  25. ↑ [?] ???????? ????-??-?? ?? ??? ????? ???? ?????????? ??? ?????? ??????? ?? ??????????? ????? ?????? ??????
  26. ↑ Temple R (2002). "Policy developments in regulatory approval". Statistics in Medicine . 21 : 2939?2948. doi : 10.1002/sim.1298 .
  27. ↑ ??.? ??.? Frum, David (2000). How We Got Here: The '70s . New York, New York: Basic Books. ????? 180. ISBN   0465041957 . Cite has empty unknown parameter: |coauthors= ( ??? ) CS1 maint: discouraged parameter ( link )
  28. ↑ Karki L (2005). "Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement". Journal of the Patent & Trademark Office Society . 87 : 602?620.
  29. ↑ [?] ????- ?? ???? ????? ????????
  30. ↑ ??????? ????? ???? ?????? ???? ?????? ????, ? ???? ????? ??????, ????? 16, 1990, ???????, ???? ??????? - ?????, ??? ??; ????? 12, ???? 4; ????? ?????, 830 ????, ?????? ???? ??????, ???????? ?? ? ???? ????? ??????, ????????? ????? 15
  31. ↑ [?] ???????? ????-??-?? ?? ??? ????? ???? ????? (FDA) ???????: ??????/??????? ???? ??? ????? ????????? ??????? ????? ??? ???? ??????
  32. ↑ Orlando V (1999). "The FDA's Accelerated Approval Process: Does the Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?". American Journal of Law and Medicine . 25 : 543?68.
  33. ↑ [??] ???????? ????-??-?? ?? ??? ????? ???? ???? ?????? ????????? ???? ????? (FDA)?? ??????
  34. ↑ http://www.npr.org/templates/transcript/transcript.php?storyId=127773447
  35. ↑ ??.? ??.? http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html
  36. ↑ [??]  PDF (119 KB) ??????? ??????? ?????? ?????? ?? ????? (FDA)
  37. ↑ [??] ? ?????? ????? (?????)
  38. ↑ [??]  PDF (28.3 KB) ????? ????????? ???????? ????? ??????
  39. ↑ Henderson, Diedtra (2006-09-23). "Panel: FDA needs more power, funds". Boston Globe . [??]
  40. ↑ [??]  PDF (279 KB) 2006 ????? ?????? ? ?????? ?? ???? ??????: ????????? ???? ???????????? ? ????? ?? ?????? ?? ???????????? ????
  41. ↑ [??] ???????? ????-??-?? ?? ??? ????? ???? The ????????? IV ????
  42. ↑ ??.? ??.? Politis P (2005). "Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing". Widener Law Review . 12 : 271.
  43. ↑ [??] ???????? ????-??-?? ?? ??? ????? ???? ??. ??. 1038 ?????? ?? ???? ?????? ??????? ????
  44. ↑ ??.? ??.? Henderson, Diedtra (September 23, 2006). Panel: FDA needs more power, funds . Boston Globe . [??]
  45. ↑ ????????? ??? ?????? ????????? ????? ?????? ?????. (2006). ? ?????? ?? ???? ??????: ????????? ???? ???????????? ? ????? ?? ?????? . ???????????? ?? ???????. ??? ????? ???? .
  46. ↑ ????? ?, ????? ???. (2009). ????? (FDA) ???????????? ???? ????? ?? ?????????? ???? ?????? . ??????????.
  47. ↑ ????????, ???????, ?????? ????? ??? ????? ????. ????????? 2003. "??? ?????? ?? 21?? ???." ??????? ?? ?????? 71. [??]
  48. ↑ ?????, ?????? ??. 2008. "??? ? ??????? ????????? ???????????? ?? ????? (FDA)." ???? ????? ??? 5(3): 316-348. [??]

??? ????? [ ?????? ??? ]

  • ????? ????? (???????? 2005) ????? ????? ????? (FDA) ???????: ??? ??? ?????? ???? ????? ?? ?????? ????? ??????(26): ????? 450?468.
  • ????? ??. ???????. ???????????? ???????? ?????: ? ????? (FDA), ?????? ???? ?? ???????? ???? ?? ??????????. ???? ?????: ??????? ?. ???, 2003. ISBN 0-375-40466-X
  • ???? ?? ????. ?????????????? ??? ????????? ? ???? ???????? ?? ??? ??????? ???????. ???? ?????: ?????? ???? ??????, 1998. ISBN 0-684-82998-3 .

????? ?????? [ ?????? ??? ]

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