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FDA Names Veteran Investigator as Head of Inspections/Investigations

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FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency...

Fulcrum Therapeutics Halts Sickle Cell Disease Program

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Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving fe...

CBER Post New E-Submission Frequently Asked Questions Guide

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FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for ...

Be Prepared for New One-Day FDA Inspections: Law Firms

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Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readi...

Former FDA and HHS Heads Opine on Next Commissioner

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Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leader...

Report Urges FDA Overhaul for Faster Reviews

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A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical de...

Guide on Reducing Animal Studies for Cancer Products

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FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conj...

ICH Q&A Document for Drug Quality Guidelines

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ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.

BPI Labs Cited After FDA Inspection

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FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks at its outsourcing facility i...

Replimune to Refile Controversial Melanoma BLA

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Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment fo...