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ICH Prep Meeting to be Held

06/03/2003

Federal Register Notice: FDA is holding a meeting entitled “Preparation for ICH Meetings in Brussels, Belgium, 7/15-18, and ...

Labeling Requirements Changed for Parenteral Products

06/03/2003

Federal Register Final rule: FDA is amending its regulations to change the labeling requirements concerning aluminum in small volu...

FDA Accepts Name Change for Ophthalmic Product

06/03/2003

Federal Register Final rule: FDA is amending the regulation that established conditions under which over-the-counter ophthalmic dr...

Record on OTC Antimicrobials Reopened

05/29/2003

Federal Register Proposed rule: FDA is reopening until 8/27, the administrative record for the rulemaking for over-the-counter top...

Conditions Proposed for GRAS Dental Drug Products

05/29/2003

Federal Register Advance notice of proposed rulemaking: FDA is issuing an advance notice of proposed rulemaking that would establi...

Panel to Discuss Serono, Axcan NDAs

05/29/2003

Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 6/25-26, from 8:30 a.m. to 5 p.m. at the ...

Periactin Not Withdrawn for S&E

05/28/2003

Federal Register Notice: FDA has determined that Periactin (cyproheptadine HCl) 4 mg tablets were not withdrawn from sale for reas...

Workshop to be Held on FDA Clinical Trial Requirements

05/28/2003

Federal Register Notice: FDA Philadelphia District is holding a workshop on FDA clinical trial statutory and regulatory requiremen...

OMB OKs Info on Adverse Reporting for Biologics

05/23/2003

Federal Register Notice: FDA’s collection of information entitled “Adverse Experience Reporting for Licensed Biologica...

Comments Sought on Importer’s Entry Notice

05/23/2003

Federal Register Notice: FDA is seeking public comments on the proposed information collection provisions for the importer's entry...