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DDMAC Cites Misbranded Vivitrol Materials

[ Price : $8.95]

DDMAC says an Alkermes patient welcome kit for Vivitrol (naltrexone) is misbranded because it minimizes important risk information...

Hill FDA Oversight to Intensify Under Republicans: FDA Matters

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FDA Matters editor Steven Grossman predicts more intense oversight and investigation hearings on Capitol Hill after the Republican...

Mercury Hazard from Amalgam Greater than Thought: 2 Studies

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A month before it hears critics of its 2009 dental amalgam rule that the device is safe, FDA is confronted by two new studies cont...

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

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

Tercica Letter Gives Insight Into DDMAC Thinking

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

FDA Proposes Graphic Cigarette Ads

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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

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Federal Register Notice: FDA releases a draft guidance on how to improve a Dear Health Care Provider letter to communicate importa...

Upsher-Smith Labs Phase 3 Extension Study

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