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Public Perception of FDA Improves

05/04/2009

FDA’s reputation with the general public has improved in the last year, according to a new Harris Interactive/HealthDay ("ht...

Hamburg Faces Senate Confirmation 5/7

05/04/2009

FDA commissioner-nominee Margaret Hamburg is scheduled to appear before the Senate Health, Education, Labor and Pensions committee...

CDER’s Autor Predicts Increased and Swift Enforcement

05/04/2009

CDER enforcement actions will continue to rise in the foreseeable future, warned Center Office of Compliance director Deborah Auto...

Lawyers Disagree on Wyeth v. Levine

05/04/2009

The recent Supreme Court decision in the case of Wyeth v. Levine, in which the plaintiff won a tort case against the drug manufact...

Guidance on Label Comprehension Studies

05/01/2009

Federal Register Notice: FDA is making available a draft guidance for industry, Label Comprehension Studies for Nonprescription Dr...

Compliance Guide for Renderers on Prohibited Feed Substances

05/01/2009

Federal Register Notice: FDA is making available a guidance, Small Entities Compliance Guide for Renderers — Substances Proh...

FDA OKs Pfizer Topical Solution for Kittens

04/30/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pfizer supplemental NADA that re...

Investigator Financial Disclosure Info Sent to OMB

04/22/2009

Federal Register Notice: FDA submits a proposed collection of information, “Financial Disclosure by Clinical Investigators,&...

Info on Rx Drug Effectiveness Sent to OMB

04/03/2009

Federal Register Notice: FDA’s proposed collection of information, “Mental Models Study of Health Care Providers' Unde...

Info on Objections and Hearings Sent to OMB

04/03/2009

Federal Register Notice: FDA’s proposed collection of information, “Filing Objections and Requests for a Hearing on a ...