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Info Collection on Regulatory Misconduct Allegations

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Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulat...

Wearable Smart Thermometer Recalled

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BearCare recalls it rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation.

Phathom Pharma Resubmits Vonoprazan NDA

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FDA accepts for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a potassium-competitive acid blocker to treat er...

GE Sonic DL Image Acquirer Cleared

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FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acq...

Ferring Gene Therapy Scale-Up Approved

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FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up ...

Guide on Contraceptive Drug Interaction Studies

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Federal Register notice: FDA posts a final guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives....

Dermatologic/Ophthalmic Drugs Panel Renewal

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Federal Register notice: FDA announces the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional t...

FDA Permanently Debars Analay Rico

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Federal Register notice: FDA issues an order to permanently debar Analay Rico from providing services in any capacity related to a...

Bipartisan Bill on Provisional FDA Approvals

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A group of bipartisan senators introduce the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (A...

FDA Needs New Policies for AI: Gottlieb

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Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integr...