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Device Firm Pays $36 Million Over Misbranding Charges

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Pennsylvania-based medical device manufacturer Biocompatibles pleads guilty to misbranding its embolic device LC Bead and will pay...

FDA Approves Gileads new Hepatitis B Therapy

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FDA approves a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic h...

No Major Changes at FDA: Pines

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Former FDAer Wayne Pines outlines three impacts of the election results on FDA in the future.

Virtus Pharmaceuticals Petition Denied on Procedural Grounds

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FDA denies on procedural grounds a Virtus Pharmaceutical petition asking it to investigate whether two producers of potassium chlo...

Americans Oppose Off-label Promotion: Consumer Reports

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Consumer Reports shares with FDA results from a new poll showing that most Americans (84%) do not want companies to be allowed to ...

21st Century Cures Bill a Disaster Still: Yale Critic

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Yale Universitys Collaboration for Research Integrity and Transparency renews its sharp criticism of the pending 21st Century Cure...

Senate and House Leaders Eager to Push Cures Act Through

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Senate and House leaders signal strong interest in seeing the 21st Century Cures Act signed into law this year.

Comments Sought on Radiation Product Requirements

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Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on reporting and recordkeepin...

Draft Guide on Surgical Aspirator Device Labeling

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Federal Register Notice: FDA makes available a draft guidance on Product Labeling for Certain Ultrasonic Surgical Aspirator Device...

Partial Clinical Hold Lifted on Adaptimmune T-cell Therapy

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FDA removes a partial clinical hold on a Adaptimmune Therapeutics planned study of its NY‑ESO SPEAR (Specific Peptide Enhanc...