FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

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...

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Federal Register Notice: FDA is extending the comment period for the draft guidance Considerations for the Design of Early-Phase C...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