FDA Related News

Medical Devices

Use 510(k) for OTC Hearing Aids: Authors

Two hospital-based doctors call on FDA to clear OTC hearing aids using the 510(k) pathway.

Medical Devices

CorticoMetrics AI-based Software Cleared for Radiologists

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

Human Drugs

Eiger Bio NDA for Rare Preemature Aging Disease

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

Medical Devices

No Enforcement for Reusing Certain Respirators

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

Biologics

Revance BLA Final Review Action Deferred Due to Covid

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

Purdue Pharma Pleads Guilty to Fraud, Kickbacks

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

Biologics

Merck BLA Filed for Pneumococcal Conjugate Vaccine

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

Biden Impact on FDA Centers/Programs Analyzed

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

Federal Register

Former Insys President Debarred by FDA

Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a person that has an appro...

Human Drugs

FDA Wants More CMC Info for Liquidia LIQ861

An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pulmonary arterial hyp...