In an online post, CDRH director Jeff Shuren discusses the end to the Centers Alternative Summary Reporting program and other changes to medical devic...
FDA posts a final guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Mat...
Teleflex Medical recalls multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to complaints about the devices connector disc...
Federal Register notice: FDA makes available a draft guidance entitled Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.
Infusion Options recalls all lots of its sterile products due to a lack of sterility assurance.
Federal Register notice: FDA announces a 9/17 public hearing entitled Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeut...
Federal Register notice: FDA submits to OMB an information collection extension for Substances Generally Recognized as Safe (GRAS): Notification Proce...
Federal Register notice: FDA amends a 5/6 Federal Register notice about a 6/20 meeting of the Oncologic Drugs Advisory Committees Pediatric Oncology S...