Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Reporting.
Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors may become loose or ...
Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.
Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations...
Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.
FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.
Federal Register notice: FDA submits to OMB information collection revisions entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...
Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people to run FDA and other...
