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FDA: PDUFA 7 CMC Commitments Complete

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FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...

Efforts Needed to Improve Health Outcomes, Califf Says

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Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...

HELP Committee Advances Biosimilar Bill

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The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...

FDA Cites SGS France Life Sciences Over Bioanalytical Method Validation

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A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involv...

J&J Reports Positive Data From Multiple Myeloma Study

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Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecva...

FDA Cites Cliantha Research on Data Integrity, Quality Unit

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FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research d...

Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

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A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand huma...

FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

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An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hu...

Diamantas Touts FDA Moves to Boost U.S. Jobs

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FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American ...

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

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FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pil...