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FDA Promotes Centralized Statistical Trial Monitoring

[ Price : $8.95]

FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.

DTC Ad Enforcement to Increase Under Trump: Panel

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Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek ...

FDA Sees New Ocaliva Liver Injuries

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FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cho...

FDA Hasnt Inspected Factory with Recalls: ProPublica

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A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multip...

Lykos to Appeal MDMA Drug Rejection

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After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...

Loper Bright May End FDA Speech Ban: Attorney

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Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Supreme Court Could Hit FDA Regulation: FDLI

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A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

Contract Lab Valisure Relinquishes its Testing Prowess

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Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issu...

FDA Denies Most Parts of 4 Dental Amalgam Petitions

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FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam...