[ Price : $8.95]
FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.[ Price : $8.95]
FDA publishes a guidance on procedures for submitting section 513(g) requests for information on medical device classification.[ Price : $8.95]
Liquidia Corp. sues FDA over the agencys recent decision to grant United Therapeutics Corp. an additional three-year exclusivity p...[ Price : $8.95]
A New York Times investigative article examines potential conflicts of interest with retiring CDRH director Jeff Shuren and his la...[ Price : $8.95]
FDA approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.[ Price : $8.95]
FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.[ Price : $8.95]
PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.[ Price : $8.95]
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regn...