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Comments Sought on ‘Enhanced Transparency’ Submissions

12/10/2015

Federal Register Notice: FDA is seeking public comment on a proposed information collection involving interviews of pharmaceutical...

FDA Sets Review Period for Fulyzaq

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Napo Pharmaceuticals’ Fulyzaq is 7,784 days for...

Review Period Set for Sirturo

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Janssen Pharmaceutica’s Sirturo is 2,213 days f...

Review Period Set for Eliquis

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Eliquis is 3,685 days fo...

Review Period Set for Visual Stimulation System

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Second Sight Medical Products’ Argus II Visual ...

Review Period Set for Bayer Animal Health’s Veraflox

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bayer Animal Health’s Veraflox is 3,285 days fo...

Guidance on Blood Donor Suitability in Ebola Outbreaks

12/03/2015

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Assessment of Blood Donor Suitabili...

Guidance on Veterinary Feed Directive Common Format

12/01/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Veterinary Feed Directive Common Format Qu...

FDA Sends Info on Tropical Disease Vouchers to OMB

11/18/2015

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Tropical Disease Priority...

Comments Sought on Safety Reporting, Electronic Submissions

11/18/2015

Federal Register Notice: FDA is seeking public comments on a proposed collection of information on the use of the FDA Electronic S...