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Dallas Public Workshop to Discuss Quality Systems

03/04/2004

Federal Register Notice: FDA’s Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with...

Mammography Panel to Meet

03/04/2004

Federal Register Notice: FDA’s National Mammography Quality Assurance Advisory Committee will meet 4/19, from 9 a.m. to 6 p....

Focus Group Info Sent to OMB

03/03/2004

Federal Register Notice: FDA’s proposed collection of information, ”Focus Groups as Used by the Food and Drug Administ...

Comments Sought on Issues for ANDA Approvals

03/03/2004

Federal Register Notice: Due to recent statutory changes, such as the Medicare Prescription Drug, Improvement, and Modernization A...

FDA OKs Vétoquinol ANADA to Treat Turkeys

03/03/2004

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

FDA Approves Alpharma NADA for Chickens

03/03/2004

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of Alpharma’s new animal drug a...

Bristol-Myers’ Cytoxan Formulation Not Withdrawn for S&E

03/01/2004

Federal Register Notice: FDA has determined that although Bristol-Myers Squibb has discontinued marketing Cytoxan, 2 g vial (cyclo...

Docket Number Corrected on Guidance Notice

02/27/2004

Federal Register Notice: FDA is correcting a docket number from a 2/10 Federal Register notice announcing the availability of a dr...

Comment Period Extended on Marketing Unapproved Drugs Guide

02/27/2004

Federal Register Notice: FDA is reopening until 4/27 the comment period on the draft guidance for industry entitled Marketing Unap...

FDA Renames, Reclassifies Embolization Devices

02/25/2004

Federal Register Proposed rule: FDA is proposing to reclassify two embolization devices to change their names, revise the identifi...