Patients for Access to Advanced Hemophilia Therapy asks FDA for a public hearing on whether patent suits have an adverse effect on the delivery of med...
FDA releases its latest batch of Warning Letters that includes South Texas Botanicals and Tris Pharma.
FDA accepts for priority review a Verastem NDA for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-ki...
FDA clears a Varian 510(k) for a new version of its Velocity cancer imaging software which includes Rapidsphere, a module for Y90 Selective Internal R...
FDA clears a Johnson & Johnson Vision Care 510(k) for the first contact lens to incorporate an additive that automatically darkens the lens when expos...
Federal Register notice: FDA submits for OMB approval an information collection extension for Class 2 Special Controls Guidance Document: Labeling for...
FDA denies an Insys Therapeutics petition asking for restrictions on ANDAs for a generic form of its Syndros.
FDA publishes an International Conference on Harmonization addendum to a 2000 guidance on clinical investigation of medicinal products in the pediatri...