FDA launches a new Web page to highlight how it uses inspections to help ensure drug safety and quality.
FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity Prototype Assessm...
FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.
FDA posts a cross-Center paper entitled Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together that ident...
Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submis...
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating an...
Federal Register notice: FDA amends certain medical device regulations to update a citation for information collection and conform the regulatory prov...
FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation of the devices therm...
