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Another Appeals Court Rejects FTC Disgorgement

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Attorney Karin Moore says the 3rd Circuit Court of Appeals has joined the 7th Circuit and two judges in the 9th Circuit in determi...

White House Relents on FDA Covid-19 Guidance

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The White House buckles under behind-the-scenes FDA resistance and allows the agency to post a controversial guidance that outline...

Fee Rate for FT 2021 Rare Pediatric Disease Voucher

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Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 202...

Workshop on Sentinel System Surveillance

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FDA and Duke Universitys Margolis Center for Health Policy plan a 10/14 annual Sentinel Initiative public workshop.

CGMP Issues at LEC Custom Products

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FDA warns Canadas LEC Custom Products about CGMP violations in the production of finished drugs at one of its manufacturing facili...

Consider Alternate Interchangeability Methods: Study

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Researchers say sponsors seeking an interchangeable designation for a biosimilar should consider alternate approaches that will me...

Essential Pharmaceutical Adulterated, Misbranded Supplements

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FDA warns Essential Pharmaceutical about multiple violations in its production of dietary supplements.

Not Enough Done on FDA Hiring, Retention: PhRMA

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PhRMA calls on FDA to take more action to meet its hiring and retention goals in the current PDUFA and BsUFA cycles.

Biosense Websters Ablation Catheter Approved

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FDA approves Biosense Websters Thermocool SmartTouch SF Ablation Catheter for treating persistent atrial fibrillation.

FDA Seeks Electronic Premarket Submissions Pilot Volunteers

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FDA issues a call for volunteers to pilot electronic delivery of premarket submissions during the Covid-19 pandemic.