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21% of FDA Staff Gone: Analysis

[ Price : $8.95]

An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...

14 States Join Mifepristone Petition to FDA

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14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...

Device Dental Bone Graft Study Guidance

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FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.

Oncology Trial Overall Survival Assessment Guide

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FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.

FDA Orphan Status for Keros Duchenne Candidate

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FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne ...

Workshop on Allergic Dermatitis Patch Test Alternatives

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FDA announces a 10/23 public workshop to discuss the regulatory status of, and potential alternatives to, patch tests used in diag...

Nucleus RadioPharma Names Former FDA Head as CEO

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Nucleus RadioPharma appoints former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer.

FDA Rejects enVVeno Medical Venous Valve PMA

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FDA issues enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat...

FDA Lifts Hold on Rockets Gene Therapy

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FDA lifts a clinical hold on Rocket Pharmaceuticals pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon di...

Impact of FDA China Cell Rule Unclear: Experts

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Experts share varying opinions with Clinical Trials Arena on the impact of an FDA rule barring biotech companies from sending cell...