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FDA Less Aggressive with Off-label Promotion: Woodcock

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CDER director Janet Woodcock acknowledges that the pendulum has swung away from aggressive FDA drug advertising and promotion enfo...

Patient Engagement Advisory Committee Meeting

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Federal Register notice: FDA announces an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations ...

CDER Priorities Include New Drugs Modernization

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CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent direct...

FDA Awards 12 Grants for Rare Disease Studies

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FDA awards 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical p...

Guide on 510(k) Benefit-Risk Factors

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FDA issues a final guidance entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifi...

Joint Panel to Review Alkermes Depression NDA

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Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive dis...

Pfizer Breakthrough Therapy Designation for Pneumococcal Vaccine

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FDA grants Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482...

Midterms Threaten FDA Funding: Alliance

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An analysis by the Alliance for a Stronger FDA says that the agencys fiscal year 2019 appropriations, which are part of a four-bil...

FTC Hits First iV Cocktails Seller

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The FDA charges A & O Enterprises, a seller of intravenously injected therapy products (iV Cocktails), with making a range of dece...

Vita Medical Spray-on Skin Cells Approved for Burns

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FDA approves a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 ...