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Erica Jefferson Returning to FDA

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FDA brings Erica Jefferson back to the agency as associate commissioner for external affairs.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include American Specialty Pharmacy and Exela Pharma Sciences.

Priority Review for Axsome AXS-05 Depression Drug

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FDA accepts for filing and grants priority review to Axsome Therapeutics AXS-05 to treat major depressive disorder.

Guide on Antisense Oligonucleotide Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Individualized Antisense Oligonucleo...

FDA Lifts Clinical Hold on Huntingtons Therapy

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FDA lifts a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntingtons diseas...

2 Bills Affecting FDA Signed Into Law

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President Biden signs into law two FDA-related bills that are intended to help lower drug/biologic prices.

Clinical Hold Lifted on UniQure Gene Therapy

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FDA removes a clinical hold against UniQures hemophilia B gene therapy program after determining it satisfactorily addressed all i...

BD Files 510(k) for Required Alaris Pump Update

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Becton, Dickinson files a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues raised l...

House Hearing on Lowering Rx Drug Prices

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The House Energy and Commerce Health Subcommittee announces a 5/4 hearing to discuss legislative proposals to lower prescription d...

Workshop Looks at OTC Drug Facts Label

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FDA announces a 6/9 workshop entitled The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021.