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Comments Extended on Generic Drug User Fee Guidance

11/27/2013

Federal Register Notice: FDA is reopening the comment period to 12/11 for the Draft Guidance for Industry on Generic Drug User Fee...

Panel to Discuss REMS Communications

11/27/2013

Federal Register Notice: FDA’s Risk Communications Advisory Committee will meet 12/17 from 9 a.m. to 5 p.m. at the FDA White...

FDA Seeks Sponsors for Study Data Pilot

11/27/2013

Federal Register Notice: CDER and CBER are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortiu...

FDA Withdraws Fleming NADA

11/26/2013

Federal Register Notice/Final rule: FDA is withdrawing approval of a Fleming Laboratories NADA for an arsanilic acid Type A medica...

Preclinical Assessment of Cellular/Gene Therapy Products

11/25/2013

Federal Register Notice: FDA is making available Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gen...

Guidance on Research IVD Product Distribution

11/25/2013

Federal Register Notice: FDA is making available a guidance entitled Distribution of In Vitro Diagnostic Products Labeled for Rese...

FDA Withdraws 3 NADAs

11/22/2013

Federal Register Notice/Final rule: FDA is withdrawing approval of three Zoetis Inc. NADAs for 3-NITRO (roxarsone) Type A medicate...

FDA Ends Veterinary Advisory Committeee

11/22/2013

Federal Register Final rule: FDA has terminated the Veterinary Medicine Advisory Committee from the agency’s list of standin...

Comments Extended on Cellular/Gene Therapy Product Trials

11/20/2013

Federal Register Notice: FDA is extending the comment period for the draft guidance Considerations for the Design of Early-Phase C...

Guidance on Name Placement in Advertising

11/20/2013