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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...

Drug User Fee Agreement Now Faces Political Debate

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FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting t...

FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

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An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spen...

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FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conj...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