FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA [BE/BA News]
a new Guidance for Industrypublished in the Federal Register on July 5th.
See esp. APPENDIX A: MAJOR DEFICIENCIES, B. Bioequivalence Deficiencies.
The quality of responses received is directly proportional to the quality of the question asked. ☼
- FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA - Helmut, 2018-08-09 10:52 [BE/BA News]