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

posted by Helmut Homepage – Vienna, Austria, 2018-08-09 10:52 (1471 d 00:15 ago) – Posting: # 19161
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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.

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