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Committee Dems Hit Azar on LDT Approvals

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House Energy and Commerce Committee Democratic leaders blast HHS secretary Alex Azar for a grave error in pulling the review of la...

Eton Pharmaceuticals NDA for Liquid Topiramate

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Eton Pharmaceuticals files an NDA for topiramate oral solution as a monotherapy for treating certain seizures and preventing migra...

FDA Wins FOIA Ruling on Confidential Info Redactions

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FDA prevails in a Freedom of Information Act lawsuit that found the agency appropriately allowed company-directed redactions of co...

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.