FDA releases a final guidance entitled Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic A...
FDA commissioner Scott Gottlieb explains the need for a new Center of Excellence for Digital Health.
FDA solicits comments on a draft guidance to update and clarify the Special 510(k) program for some medical devices.
FDA announces new and expanded research efforts into compounded drugs.
Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents.
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug produc...
Federal Register notice: FDA makes available a draft guidance entitled Insanitary Conditions at Compounding Facilities.
Federal Register notice: FDA makes available a final guidance entitled Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities....