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Supplement Owner Guilty of Selling Unapproved Products

[ Price : $8.95]

The owner of Daniel Chapter One, James Feijo, pleads guilty in Providence, RI federal court to marketing and selling unapproved pr...

FDA Panel Criticizes Bayer, FDA Over Essure Device

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FDA and Bayer receive major criticism from an FDA advisory committee for not requiring or conducting a randomized clinical trial t...

FDA OKs New Dosing Labeling for BMS Reyataz

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FDA approves revisions to Bristol-Myers Squibbs Reyataz (atazanavir) oral powder label to include dosing recommendations for patie...

FDA Concerned Over Petitions Seeking Approval Delays

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FDA says it continues to be concerned that companies are still submitting citizen petitions that are intended primarily to delay t...

FDA Hires New Internal Lab Safety Expert

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FDA says it has hired an unnamed expert to join the agency next as the newly established director of laboratory safety and securit...

FDA Awards Grant for Prader-Willi Syndrome Study

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FDAs Office of Orphan Products Development awards a $1 million research grant to Rhythm Metabolic to back a Phase 2 trial of setme...

Professional Groups Rebuff FDA on Testosterone

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Two professional endocrinology groups say they disagree with a March FDA caution about not prescribing testosterone replacement th...

FDA Revises Tobacco Environmental Impact Regs

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Federal Register Final rule: FDA revises regulations to allow certain classes of actions on tobacco product applications to be exc...

FDA Clears BD Life Panel to Detect Parasites

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FDA clears BD Life Sciences BD MAX Enteric Parasite Panel as an aid in diagnosing infectious gastroenteritis.

IDE Review Times Still Improving: Officials

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CDRHers Jeffrey Shurin and Owen Faris discuss three Center actions that have led to faster IDE reviews and approvals.