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Federal Register Notice: FDA is extending the comment period for the draft guidance Considerations for the Design of Early-Phase C...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

Workshop on Devices to Treat Obesity

11/20/2013

Federal Register Notice: FDA will hold a public workshop 12/19-20 entitled “Changing Regulatory and Reimbursement Paradigms ...

FDA Corrects Rule on Tobacco Rule

11/20/2013

Federal Register Final rule: FDA published a final rule in the 11/30/10 Federal Register amending certain regulations to include t...

Guidance on Transfusion/Transplant Test Kits

11/20/2013

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Recommendations for Premarket No...

Comments Sought on Dietary Ingredient Info

11/14/2013

Federal Register Notice: FDA is inviting public comments on the proposed information collection provisions of existing regulations...

Guidance on Device Development

11/14/2013

Federal Register Notice: FDA is making available a draft guidance entitled Medical Device Development Tools. It provides guidance ...

Comments Sought on Patent Regulations & FDA Review Time

11/14/2013