Two Hogan Lovells attorneys describe provisions in an FDA final guidance on the voluntary STeP program for medical devices.
A Florida federal court throws out multidistrict litigation against manufacturers and distributors of generic Zantac.
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.