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FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conj...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

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...

DexCom Alert on Stolen Glucose Monitoring Sensors

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DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the comme...