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Guide on Submitting Continuous Glucose Monitoring Data

[ Price : $8.95]

FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during...

Boston Scientific Device Correction on Certain Pacemakers

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Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy p...

White House Reportedly Moves to Oust Commissioner Makary

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Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy

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FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cho...

Atara says FDA outlined potential path for Cell Therapy Resubmission

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Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path ...

Postapproval Pregnancy Safety Studies Guidance Available

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FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs...

CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities

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CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug ...

Advertising Experts Critique FDAs Increasing Enforcement

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Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion sinc...

Sanofi Seeks Removal of Tzield From FDA Priority Review Program

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Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agencys National Priority Voucher review program following a...

Brookings Economist Backs FDA Biosimilar Draft Guide

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A Brookings Institution health economist voices support for FDAs revisions to a guidance on questions and answers about biosimilar...