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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 Posts New ICH Guide on Mutagenic Impurities

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FDA posts a new International Conference on Harmonization guidance entitled M7(R1) Addendum to ICH M7: Assessment and Control of D...

Regs on Classifying Tobacco Product Regulation

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Federal Register Proposed rule: FDA proposes regulations to describe when a product derived from tobacco will be subject to regula...

FDA Approves 2 New Novo Nordisk Diabetes Therapies

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FDA approves Novo Nordisks Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to i...

Supplement Owner Guilty of Selling Unapproved Products

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

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...