FDA lists six of its 2019 activities to promote medical device cybersecurity safety and awareness.
FDA grants Shreis Scalene Sciences a Breakthrough Device designation for Cytotron, a whole-body therapeutic medical device for use in causing degenera...
FDA grants Recro Pharmas appeal of an agency complete response letter for the firms IV meloxicam.
ICU Medical recalls one single lot of lactated ringers injection, USP, and one single lot of 0.9% sodium chloride injection, USP, due to the presence ...
FDA grants CARsgen Therapeutics a Regenerative Medicine Advanced Therapy designation for its investigational CT053 CAR-T cell therapy for multiple mye...
Federal Register notice: FDA makes available a draft guidance on Providing Regulatory Submissions in Electronic Format: IND Safety Reports.
In a split vote, FDAs Bone, Reproductive and Urologic Drugs Advisory Committee votes 9 to 7 to recommend that the agency remove from the market Amag P...
FDA issues a guidance on an interim regulatory policy for outsourcing facilities compounding drugs from bulk drug substances.