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6 Ways to Improve Trial Diversity

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Three Syneos Health executives give FDA six ways to strengthen its guidances on clinical trial diversity.

Regulatory Review Didnt Slow Covid Vaccines: Marks

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CBER director Peter Marks urges a move to continuous manufacturing for vaccines to gain from lessons learned during Covid-19 vacci...

2 Trial Coordinators Say They Falsified Data

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Two Tellus Clinical Research study coordinators in Florida plead guilty to falsifying clinical trial data.

BioCircuit Technologies 510(k) for Nerve Tape

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FDA clears a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of tr...

Draft Guide on Dose Banding in Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Human Prescription Drug and Biological Products Labeling f...

Orange Book Therapeutic Equivalence Guide

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Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Therapeutic Equivalence that explains how ...

New Renuvion/J-Plasma Handpiece Available: FDA

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FDA says it has cleared the Renuvion APR Handpiece for specific subcutaneous dermatological and esthetic procedures.

Whitmer Wants Mifepristone REMS Lifted

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Michigan Gov. Gretchen Whitmer urges FDA to eliminate all REMS restrictions from the mifepristone abortion drug.

AdvaMed Supports Diagnostics Reforms in User Fee Reauthorization

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The Advanced Medical Technology Association urges the House and Senate to come to terms on a FDA user fee reauthorization package ...

Panel to Discuss Certain Accelerated Approvals

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Federal Register notice: FDA announces a 9/22-23 Oncologic Drugs Advisory Committee meeting that will discuss an NDA for Spectrum ...