Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
fda-drug · Food and Drug Administration · Rule · Published 2009-07-28 · Effective 2010-01-25 · 74 FR 37163
Document
Document number
E9-17963
Federal Register citation
74 FR 37163
CFR reference
21 CFR 314
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2009-07-28
Effective date
2010-01-25
HHS docket
Docket No. FDA-2008-N-0341
Abstract
The Food and Drug Administration (FDA) is 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. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.