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TV Spot Creates Otezla Misleading Safety Impression: OPDP

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CDERs Office of Prescription Drug Promotion says that a Celgene TV ad for Otezla undermines communication of important risk inform...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Pocono Coated Products and United Contact Lens.

President Obama Signs Cures Act Into Law

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President Obama signs into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 1...

FDA Taps DoJ Lawyer for CDER Compliance Head

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FDA selects Department of Justice Office of International Affairs attorney Donald D. Ashley as CDERs next Office of Compliance dir...

Final Guidance on Device Emerging Signals

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FDA finalizes a guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) that describes CD...

CDRH Clarifies When Device MDR Reporting is Required

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A CDRH conference call clarifies when medical device firms are required to file Medical Device Reporting submissions and answers q...

Comments Sought for New Blood Donor Questionnaire

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Federal Register Notice: FDA seeks comments on a new information collection related to Donor Risk Assessment Questionnaire for FDA...

Regulatory Review Period for GSKs Nucala

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Federal Register Notice: FDA determines the regulatory review period for patent extension purposes of GlaxoSmithKlines Nucala (mep...

FDA Corrects Foreign Drug Registration Notice

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Federal Register Final Rule Correction: FDA corrects a final rule entitled Requirements for Foreign and Domestic Establishment Reg...

Vericels Maci Approved for Knee Cartilage Repair

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FDA approves a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, ful...