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Upsher-Smith Labs Phase 3 Extension Study

[ Price : $8.95]

Upsher-Smith adds an open-label extension study to PREVAIL, a global Phase 3 trial for USL255 (extended-release topiramate), indic...

CBER Issues FY 2009 Report

[ Price : $8.95]

CDER issues its annual report for FY 2009 highlighting its work on the pandemic flu.

Group Seeks Plasma Protein 'Biosimilar' Exclusion

[ Price : $8.95]

The Plasma Protein Therapeutics Association urges FDA to exclude plasma-derived therapies and their recombinant DNA technology ana...

CGMP Problems Found at Sepal Reproductive Devices

[ Price : $8.95]

FDAs New England District Office warns Sepal Reproductive Devices about multiple regulatory violations.

Tercica Letter Gives Insight Into DDMAC Thinking

[ Price : $8.95]

Attorney Arnold Friede says FDAs Warning Letter on Increlex professional promotional materials gives insight into the agencys defi...

FDA Proposes Graphic Cigarette Ads

[ Price : $8.95]

Federal Register Proposed rule: FDA proposes to amend its regulations on health warning on cigarette packages and ads to implement...

Comments Sought on Device Tracking

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on Medical Devices; Device Tracking 21 CFR Part 821.

Guidance on Dear Health Care Provider Letters

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Federal Register Notice: FDA releases a draft guidance on how to improve a Dear Health Care Provider letter to communicate importa...

FDA Reviewers Question Lupus Drug's Risk/Benefit

[ Price : $8.95]

An FDA review summary of Human Genome Sciences' BLA for lupus therapy Benlysta (belimumab) shows that the serious risks were great...

Utah False Claims Suit Against Avandia 'Wonder' Drug

[ Price : $8.95]

Utah files a state false claims suit against GlaxoSmithKline for allegedly marketing Avandia as a new wonder drug to treat Type 2 ...