FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

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Federal Register Notice: FDA is making available a draft guidance, Impact-Resistant Lenses: Questions and Answers.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

FDA to Ensure Exocrine Pancreatic Insufficiency Drugs

10/26/2007

Federal Register Notice: FDA intends to continue to exercise enforcement discretion to ensure the continued availability of exocri...

OMB OKs Info on Continuous Marketing Applications

10/25/2007

Federal Register Notice: FDA’s collection of information, Guidance for Industry on Continuous Marketing Applications: Pilot ...

FDA OKs Luitpold Pharma sNADA on Phenylbutazone

10/25/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Luitp...