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FDA Taking Expedited IND Pilot Applications

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FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8...

FDA Launches Medical Device Regulatory Reliance Portal

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CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions ...

Psychedelic Drug Hearing Focuses on Access, Safety

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Stakeholders stress issues involving access and safety at an FDA hearing on psychedelic drug regulation.

FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

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FDA agrees to key elements of Rocket Pharmaceuticals modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the com...

Bill to Make Pediatric Rare Disease Voucher Permanent

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Six House members introduce bipartisan legislation to make the FDA Rare Pediatric Disease Priority Review Voucher Program permanen...

Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting

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Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton ...

CGMP Issues at Bausch and Lomb Tampa Facility

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FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.

Etcamah Misses Endpoint in First-Line Breast Cancer Trial

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AstraZeneca says that its Etcamah (camizestrant) failed to significantly improve progression-free survival in the Phase 3 SERENA-4...

FDA Needs Workforce Rebuilding, Less Political Interference: Sinha

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Saint Louis University law professor Michael S. Sinha says FDAs next commissioner should focus on rebuilding the agencys depleted ...

Scholar Rocks Spinal Muscular Atrophy Therapy Approved

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FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.