Federal Register notice: FDA issues a final rule to amend its regulations on internal agency supervisory review of certain decisions related to device...
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of a nonvoting industry representat...
Sens. Warren and Murray ask FDA to answer questions about the CDRH progressive approval of medical devices program, which they say was denied by forme...
FDA issues two guidance on CDRH appeals processes for outside stakeholders.
Federal Register notice: FDA announces a 9/10 Patient Engagement Advisory Committee meeting to discuss and make recommendations on Cybersecurity in Me...
FDA warns Aurobindo Pharma about CGMP deviations at an API manufacturing facility in India.
Federal Register notice: FDA reopens the comment period for the notices that published in the Federal Register of 4/15 and 4/28 regarding issues relat...
Federal Register notice: FDA corrects a 9/5/2017 notice entitled Providing Regulatory Submissions in Electronic Format Content of the Risk Evaluation...