Bioequivalence and Bioavailability Forum • Refuse-to-Receive Standards final guidance

Refuse-to-Receive Standards final guidance [Regulatives / Guidelines]

posted by Samaya B – India, 2014-09-17 12:25 (4301 d 18:36 ago) – Posting: # 13527
Views: 4,175

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Draft guidance on "ANDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits"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]

Refuse-to-Receive Standards final guidanceSamaya B 2014-09-17 10:25
- USFDA Guideline Revision – Refuse-to-Receive Standards sameep 2015-05-29 08:33