HHS says CBER director Vinay Prasad will step down at the end of April.
FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to ...
An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committees.
A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.
FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an in...
FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has been classified as Clas...
FDA deputy commissioner for operations and chief operating officer Barclay Butler announces his retirement in the coming months.
Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDAs new inspection approach for medical device manufacturer...
