Draft guidance for industry, entitled ANDA Submissions [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2014-06-13 10:20 (4395 d 17:13 ago) – Posting: # 13064
Views: 1,754

Dear All,
FDA published a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled ANDA Submissions--Content and Format of Abbreviated New Drug Applications

Regards,
Suchit Bhavsar

Edit: Comments should be submitted by August 11, 2014. Direct links[Helmut]

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