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Helmut ★★★   Vienna, Austria, 2018-08-09 12:52 (2085 d 11:20 ago) Posting: # 19161 Views: 2,283 |
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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. — 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 |
Ing. Helmut Schütz