FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to ...
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...
A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing facilities that are marketing ophthalmic bevacizum...
Bipartisan leaders of the Senate Select Committee on Aging ask CVS, Walgreens, and Walmart for additional information on their efforts to protect the ...
A senior FDA official sharply criticizes UniQures investigational gene therapy for Huntington's disease, calling it a failed product and casting doubt...
FDA approves Janssen Biotechs Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for certain adult patients w...
The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. with concealing serious adverse events including ...
