Bioequivalence and Bioavailability Forum 00:31 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA [BE/BA News]

posted by Helmut Homepage - Vienna, Austria, 2018-08-09 10:52  - Posting: # 19161
Views: 478

Dear all,

a new Guidance for Industry

ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA

was published in the Federal Register on July 5th.
See esp. APPENDIX A: MAJOR DEFICIENCIES, B. Bioequivalence Deficiencies.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,931 posts in 4,039 threads, 1,285 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).

A drug is not bad. A drug is a chemical compound.
The problem comes in when people who take drugs treat them
like a license to behave like an asshole.    Frank Zappa

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed