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FDA Guide on Patient Preferences in Device Submissions

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FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycl...

Editorial Criticizes Makary Over Leadership Decisions

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The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

Medtronic Wins Expanded Clearance for AXiS System

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Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.

FDA Grants Accelerated Approval to Rockets Gene Therapy

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FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children wi...

FDA Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility

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FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.

Wave Life Sciences Reports Mixed Data on Obesity Therapy

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Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy ...

FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

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Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury ...

Podcast Explains New Bayesian Methods Trial Guidance

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On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian me...

FDA Considering Industry PDUFA 8 Incentive Proposal

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FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from i...

GDUFA Research Helped Product-Specific Guidances: Report

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The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guida...