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FDA Sends Info on Postmarketing Studies to OMB

11/05/2003

Federal Register Notice: FDA’s proposed collection of information, ”Draft Guidance for Industry: Reports on the Status...

Guidance on Modular PMA Review

11/03/2003

Federal Register Notice: FDA is making available a guidance for industry entitled Premarket Approval Application Modular Review. T...

Guidance on Product Recalls

10/31/2003

Federal Register Notice: FDA is making available a guidance document for industry entitled Product Recalls, Including Removals and...

FDA OKs Monsanto sNADA to Revise Labeling

10/31/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug app...

Info on Biologics Labeling Sent to OMB

10/31/2003

Federal Register Notice: FDA’s proposed collection of information, entitled “Certain Biologics Labeling” has bee...

Panels to Discuss Suicidality in Antidepressant Trials

10/31/2003

Federal Register Notice: FDA will hold a meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommitte...

Discussions Postponed for Veterinary Meeting

10/31/2003

Federal Register Notice: FDA is amending the notice of meeting of the Veterinary Medicine Advisory Committee to reflect changes in...

FDA OKs Intervet NADA

10/31/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an NADA filed by Intervet, Inc. fo...

Endotoxin Assay in Class II

10/31/2003

Federal Register Final rule: FDA is classifying the endotoxin assay into Class II (special controls) in response to a petition. Th...

FDA Corrects Blood Labeling Proposed Rule

10/27/2003

Federal Register Proposed rule: FDA is removing an incorrect paragraph from a 7/30 proposed rule that proposed to revise the label...