FDA issues a draft guidance with recommendations for designing and conducting maximal usage tests for topical active ingredients being considered for ...
FDA clears a Providence Medical Technology 510(k) for its DTrax Spinal System, indicated for use in posterior cervical fusion in patients with cervica...
Federal Register notice: FDA makes available a guidance entitled Bioanalytical Method Validation.
Federal Register notice: FDA makes available a guidance entitled Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.
Federal Register notice: FDA posts a list of PMAs that have recently been approved.
The U.S. House of Representatives passes S. 204, the Senate version of the Right to Try Act that was passed by that chamber 8/2017.
FDA commissioner Scott Gottlieb tells the Alliance for Regenerative Medicine that the agency will soon release additional guidance on gene therapy man...
PhRMA asks FDA to clarify several elements of its model-informed drug development pilot program proposal.