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CorticoMetrics AI-based Software Cleared for Radiologists

[ Price : $8.95]

FDA clears a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists ...

Eiger Bio NDA for Rare Preemature Aging Disease

[ Price : $8.95]

FDA approves an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and proces...

No Enforcement for Reusing Certain Respirators

[ Price : $8.95]

FDA publishes a guidance for using bioburden reduction systems with dry heat to reuse certain filtering facepiece respirators.

Revance BLA Final Review Action Deferred Due to Covid

[ Price : $8.95]

FDA defers its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodula...

Purdue Pharma Pleads Guilty to Fraud, Kickbacks

[ Price : $8.95]

Purdue Pharma pleads guilty to three felony counts as part of a plea agreement announced in October.

Merck BLA Filed for Pneumococcal Conjugate Vaccine

[ Price : $8.95]

Merck submits a BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and ol...

Biden Impact on FDA Centers/Programs Analyzed

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Three Covington & Burling attorneys analyze how a Biden administration may make its mark on FDA Centers and programs.

HHS Withdrawing FDA Compliance Guide on Unapproved Drugs

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Federal Register notice: HHS announces its intent to withdraw FDAs Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.10...

Combination Product Jurisdiction Info Collection

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Federal Register notice: FDA sends to OMB an information collection revision entitled Product Jurisdiction and Combination Product...

Info Collection on Compounding Outsourcing Facilities

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information to Understand Challen...