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Panel to Discuss Permanent Sterilization Method

11/09/2007

Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet 1...

Public Meeting Slated on Epinephrine MDIs

11/08/2007

Federal Register Proposed rule: FDA will hold a public meeting 12/5 to solicit comments on a 9/20 proposed rule that would amend F...

Blood Regulations Updated

11/08/2007

Federal Register Proposed rule: FDA proposes to revise and update the regulations applicable to blood and blood components, includ...

FDA Withdraws Multiple NDAs, ANDAs

11/07/2007

Federal Register Notice: FDA is withdrawing approval of 73 NDAs and 62 ANDAs from multiple applicants. The holders of the applicat...

FDA OKs Norbrooks Labs sANADA for Bovine Parasites

11/07/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Norbrook Laboratories supplement...

Workshop on Adolescent OTC Drug Use

11/05/2007

Federal Register Notice: FDA, the National Institutes of Health (NIH), and the Consumer Healthcare Product Association are plannin...

Panel to Discuss Genentech’s Avastin

11/05/2007

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 12/5, from 8 a.m. to 5 p.m. at the Hilton Washin...

Guidance on Blood Establishment Computer Validation

10/29/2007

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Blood Establishment Computer System Vali...

Guidance on DNA Vaccines Development

10/29/2007

Federal Register Notice: FDA is making available the Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious...

Guidance on Impact-Resistant Lenses

10/26/2007

Federal Register Notice: FDA is making available a draft guidance, Impact-Resistant Lenses: Questions and Answers. It answers manu...