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Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submis...
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating an...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FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation of the devices therm...
FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on medical device submissions.
