Samaya B ☆ India, 2014-09-17 12:25 (3507 d 13:52 ago) Posting: # 13527 Views: 2,979 |
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Hi All, FDA has published: Final guidance on "ANDA Submissions ― Refuse-to-Receive Standards" http://web.archive.org/web/20141009133427/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf Draft guidance on "ANDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf Thanks. Regards, Samaya. Edit: Changed URL of RtR Guidance to webarchive. [Helmut] |
sameep ☆ India, 2015-05-29 10:33 (3253 d 15:44 ago) @ Samaya B Posting: # 14880 Views: 2,215 |
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Dear All, USFDA published Revision 1 of "ANDA Submissions – Refuse-to-Receive Standards" Regards, Sameep. Edit: Moved to suitable thread. [Helmut] Edit: Revision 2 (December 2016) [Helmut] |