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Draft Guide on Transdermal Irritation Studies

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Federal Register notice: FDA makes available a draft guidance entitled Assessing the Irritation and Sensitization Potential of Tra...

List of Information Collections Approved by OMB

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Federal Register notice: FDA publishes a list of information collections that have been recently approved by OMB.

CBER FY 2018 Recalls

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CBER lists FY 2018 recall posting statistics.

Draft Guide on Drug Patch Adhesion Studies

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Federal Register notice: FDA makes available a revised draft guidance entitled Assessing Adhesion With Transdermal and Topical Del...

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Biotechnology Innovation Organization submits comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demon...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