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When a Dispute Resolution Denial is a Win

[ Price : $8.95]

Two Hyman, Phelps attorneys say there are times when a formal dispute resolution request can lead to an alternative path forward t...

CDER Workplace Harassment, Civility Task Force

[ Price : $8.95]

CDER launches a task force to assess and improve the Center workplace culture in terms of harassment, bullying, and civility.

Expanded Standard in Special 510(k) Program Guidance

[ Price : $8.95]

Hogan Lovells attorneys review the changes in a new FDA draft guidance on the Special 510(k) Program.

Draft Guide on Transdermal Irritation Studies

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Assessing the Irritation and Sensitization Potential of Tra...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Federal Register notice: FDA makes available a revised draft guidance entitled Assessing Adhesion With Transdermal and Topical Del...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...