Former CDRH director John C. Villforth passes at the age of 88.
FDA issues a proposed rule setting requirements related to the content, format and review and communications procedures for premarket tobacco product ...
FDA releases five guidances relating to expanding the 510(k) program that the Safety and Performance Based Pathway.
FDA solicits comments on abuse-deterrent formulations for prescription stimulants.
Federal Register notice: FDA seeks comments on an information collection extension for it MedSun adverse event program for medical devices.
Federal Register notice: FDA posts a draft guidance entitled Safer Technologies Program for Medical Devices, a new, voluntary program for certain devi...
Federal Register notice: FDA makes available a final guidance entitled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of...
FDA updates its list of drugs for which the agency has received a reference-listed drug access inquiry.