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RegisterFDA: ANDA Submissions—Amendments to ANDAs Under GDFUA [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2018-08-09 12:52 (2874 d 06:46 ago) – Posting: # 19161
Views: 3,496
Dear all,
a new Guidance for Industry
See esp. APPENDIX A: MAJOR DEFICIENCIES, B. Bioequivalence Deficiencies.
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.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- FDA: ANDA Submissions—Amendments to ANDAs Under GDFUAHelmut 2018-08-09 10:52
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Ing. Helmut Schütz