Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal
fda-drug · Food and Drug Administration · Rule · Published 2009-02-10 · 74 FR 6541
Document
Document number
E9-2746
Federal Register citation
74 FR 6541
CFR reference
21 CFR 314
Type
Rule
Action
Direct final rule; withdrawal.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2009-02-10
HHS docket
Docket No. FDA-2008-N-0341
Abstract
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.