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Postapproval Pregnancy Safety Studies Guidance Available

[ Price : $8.95]

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

Guide on Submitting Continuous Glucose Monitoring Data

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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 ...

New CDER Biologics Compliance Program Explained

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Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...

Report says Makary May Face Ouster Amid White House Tensions

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Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...

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...