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Imprese · 10/02/20091 min di lettura
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →