FDA Related News

Human Drugs

Amgen Seeking Expanded Uplizna Use

Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia ...

Medical Devices

FDA Device Data Integrity Notifications

Two Akin Gump attorneys discuss a new FDA Web page with information on medical device data integrity.

Human Drugs

CGMP Deviation in Chemspec Chemicals Inspection

FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.

Human Drugs

7 Acne Products Recalled for Benzene: FDA

FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possible benzene contamin...

Medical Devices

Regulate NarxCare as Software as Medical Device: Petition

The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program risk-scoring algori...

FDA General

DoJ Lawyer Tapped as FDA Chief Counsel

HHS appoints Justice Department attorney Hilary Perkins to serve as FDA chief counsel.

Medical Devices

J&Js Monarch Quest Bronchoscopy Navigation Cleared

FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted bronchoscopy.

Federal Register

Comments Reopened on Good Clinical Practice Guide

Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.

Biologics

Priority Review for DMD Cardiomyopathy BLA

FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy.

Zenrelia Promotions False and Misleading: FDA

FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representations about the canine...