FDA posts eight generic drug research priority initiatives for FY 2023.
FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause radio interference w...
FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing applications.
The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity.
FDA commissioner Robert Califf says he hopes Congress will include regulation of laboratory-developed tests and several other issues in a December fun...
FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel, 0.075 mg), ...
FDA accepts for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventing recurrent C. diffi...
Federal Register notice: FDA announces an 11/17 public workshop entitled Quantitative Brain Amyloid PET Imaging in Patients with Alzheimers Disease....
