FDA grants Harpoon Therapeutics an orphan drug designation for HPN217 for treating multiple myeloma.
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.