FDA issues an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in several Illumina laboratory instruments.
FDA approves a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based product to prevent recur...
Public Citizen calls on FDA to promptly add Covis Pharmas Makena to the official list of drugs that have been withdrawn for reasons of safety or effec...
Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Approved New Animal Drugs...
Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life-threatening disease...
The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and recommendations to impr...
FDA clears two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing.
FDA publishes a guidance with general standards for registering with the CVM electronic submission system.
