Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule
other · Food and Drug Administration · Rule · Published 2002-12-19 · Effective 2003-02-18 · 67 FR 77668
Document
Document number
02-31996
Federal Register citation
67 FR 77668
CFR reference
21 CFR 314
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-12-19
Effective date
2003-02-18
HHS docket
Docket No. 98N-0778
Abstract
The Food and Drug Administration (FDA) is amending its regulations on bioavailability and bioequivalence and on the content and format of an abbreviated application to reflect current FDA policy and to correct certain typographical and inadvertent errors. This action is intended to improve the accuracy and clarity of the regulations.