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Docket Established for Device Development

04/22/2004

Federal Register Notice: FDA is establishing a public docket to obtain input on activities that could reduce existing hurdles in m...

Changes to Advisory Panel Meeting Notice

04/22/2004

Federal Register Notice: FDA is amending the notice of a 5/6-7 meeting of the Nonprescription Drugs Advisory Committee and the Der...

Info on E-mailing CVM OK’d by OMB

04/21/2004

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on How to Use E-Mail to Submi...

Guidance on Environmental Impact of Veterinary Products

04/21/2004

Federal Register Notice: FDA is releasing for comments a draft guidance entitled Environmental Impact Assessments for Veterinary M...

OMB OKs Info On E-mail Requests for Animal Drug Meeting

04/21/2004

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on How to Use E-Mail to Submi...

OMB OKs Info On Postmarketing Studies

04/16/2004

Federal Register Notice: FDA’s collection of information entitled “Postmarketing Studies for Human Drugs and Licensed ...

Exemption for Isocarboxazid Products is Revoked

04/16/2004

Federal Register Notice: FDA is revoking the temporary exemption that has allowed isocarboxazid products to remain on the market b...

FDA OKs P&U Equine sNADA

04/15/2004

Federal Register Notice: FDA has approved a supplemental NADA filed by Pharmacia & Upjohn, Co. that provides revised susceptibilit...

FDA Seeks NIH Pediatric Studies for 4 Drugs

04/15/2004

Federal Register Notice: FDA has referred Elan Pharmaceuticals’ Zonegran (zonisamide), GlaxoSmithKline’s Wellbutrin an...

Guidance for Surgeon Glove Powder PMAs

04/13/2004

Federal Register Notice: FDA is making available a guidance entitled Premarket Approval Applications (PMA) for Absorbable Powder f...