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Panel to Discuss Crestor

06/05/2003

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 7/9 from 8:30 a.m. to 5 p.m. ...

Comment Period Reopened on Analgesic Ingredients

06/04/2003

Federal Register Proposed rule: FDA is reopening until 9/2, the comment period on the agency's proposal to amend the tentative fin...

Final Monograph on Skin Protectant Drug Products

06/04/2003

Federal Register Final rule: FDA is issuing a final rule in the form of a final monograph establishing conditions under which OTC ...

Animal Drug Sponsor Changed to Farnham

06/04/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for an approved new animal...

Guidance on Ensulizole, Hypromellose, Meradimate Labeling

06/03/2003

Federal Register Notice: FDA is making available a guidance for industry entitled Drug Products Containing Ensulizole, Hypromellos...

Guidance on Surgical Suture Devices

06/03/2003

Federal Register Final rule: FDA is issuing a final rule to amend the classification regulations for eight surgical suture devices...

Guidance on Advisory Panel Pediatric Expertise

06/03/2003

Federal Register Notice: FDA is making available a guidance entitled Pediatric Expertise for Advisory Panels; Guidance for Industr...

Comments Sought on Unapproved Devices Exports

06/03/2003

Federal Register Notice: FDA is seeking public comment on reporting requirements for firms that intend to export certain unapprove...

GMP Public Workshop Series Slated

06/03/2003

Federal Register Notice: FDA is sponsoring a series of public workshops to discuss current good manufacturing practice (CGMP) issu...

Enbrel, Fibromyalgia Are Topics for Panel Meeting

06/03/2003

Federal Register Notice: FDA will hold a meeting of the Arthritis Advisory Committee 6/23-24, from 8 a.m. to 5 p.m. at the Holiday...