The FDA Digital Health Center of Excellence issues an action plan for artificial intelligence and machine learning software as a medical device.
Federal Register notice: FDA seeks comments on an information collection extension entitled 513(g) Request for Information.
Federal Register notice: FDA corrects a 12/21/2020 Federal Register notice seeking comments on an information collection extension entitled Export of ...
Federal Register notice: FDA announces a 2/17 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to review a PM...
FDA accepts for priority review a Bayer NDA for finerenone, an investigational drug for patients with chronic kidney disease and Type 2 diabetes.
FDA commissioner Stephen Hahn and principal deputy commissioner Amy Abernathy describe an agency framework for needed research into CBD product uses a...
A Pew Charitable Trusts issue brief calls for legislation to give FDA authority over laboratory-developed tests.
Three major healthcare organizations petition FDA not to authorize Floridas drug importation proposal.