Bioequivalence and Bioavailability Forum

Samaya B
☆

India,
2014-09-17 12:25
(4299 d 09:12 ago)

Posting: # 13527
Views: 4,167

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

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Draft guidance on "ANDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits"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 (4045 d 11:04 ago) @ Samaya B Posting: # 14880 Views: 3,085	USFDA Guideline Revision – Refuse-to-Receive Standards Post reply
	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]