FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.
FDA publishes a guidance on procedures for submitting section 513(g) requests for information on medical device classification.
Liquidia Corp. sues FDA over the agencys recent decision to grant United Therapeutics Corp. an additional three-year exclusivity period for Tyvaso DPI...
FDA approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.
A New York Times investigative article examines potential conflicts of interest with retiring CDRH director Jeff Shuren and his lawyer wife who repres...
FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.
PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regneron BLA for a multi...
