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FDA Sends Orphan Drug Info to OMB

05/27/2004

Federal Register Notice: FDA’s proposed collection of information entitled “Orphan Drug Products” has been submi...

Info on Cellular and Tissue Products Sent to OMB

05/27/2004

Federal Register Notice: FDA’s proposed collection of information, “Human Cells, Tissues, and Cellular and Tissue-Base...

Nominations Sought for CDRH Panels

05/27/2004

Federal Register Notice: FDA is requesting nominations for voting members to serve on certain CDRH device panels of the Medical De...

List of Orphan Drug and Biological Designations Released

05/27/2004

Federal Register Notice: FDA is making available a cumulative list of orphan drug and biological designations as of 12/31/03. The ...

FDA Publishes List of CBER-approved PMAs

05/27/2004

Federal Register Notice: FDA is publishing a list of premarket approval applications (PMAs) that have been approved by CBER. This ...

Panel to Discuss Eyetech Macular Degeneration NDA

05/27/2004

Federal Register Notice: FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will meet 8/27, from 8 a.m. to 5:30 p.m....

Manufacturing Subcommittee to Meet

05/27/2004

Federal Register Notice: FDA’s Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science will meet 7/2...

FDA Amends Regs for Liquid, Free-Choice Medicated Feed

05/27/2004

Federal Register Final rule: FDA is changing the regulations for liquid medicated feed and free-choice medicated feed. This change...

Guidance on BA/BE Testing Samples

05/26/2004

Federal Register Notice: FDA is making available a guidance for industry entitled Handling and Retention of BA and BE Testing Samp...

Guidance on Pediatric Device Premarket Assessment

05/14/2004

Federal Register Notice: FDA is making available a guidance entitled Premarket Assessment of Pediatric Medical Devices that presen...