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Lawmakers Seek Answers on FDA Digital Health Pathway

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Three Democratic senators led by presidential hopeful Elizabeth Warren raise concerns about CDRHs regulation of digital health dev...

Advisors Back Rituxan Biosimilar

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Members of the FDA Oncologic Drugs Advisory Committee vote unanimously to recommend approval of a Celltrion biosimilar to Biogens ...

Clinical Hold Lifted on CRISPR Gene Therapy

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FDA lifts a clinical hold against a CRISPR Therapeutics and Vertex Pharmaceuticals IND for CTX001 for treating sickle cell disease...

BIO Comments on Opioid Use Disorder Guidance

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Biotechnology Innovation Organization submits comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demon...

Vapotherm Ventilator Cleared for Expanded Use

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FDA clears a Vapotherm 510(k) for its latest version of its Precision Flow Hi-VNI system, which includes a new product category an...

Comments Sought on WHO Drug Scheduling for 16 Drugs

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Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impa...

Feds Back Merck in Fosamax Warning Case

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A federal government brief tells the Supreme Court that the 3rd Circuit Court of Appeals erred in reversing a lower court decision...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Becton Dickinson.

QS Violations at BD Manufacturing Facility

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FDA warns Becton Dickinson about Quality System issues at one of its manufacturing facilities.

New TDS Generic Drug Development Guidances

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FDA issues guidances to promote development of generic transdermal and topical delivery systems.