Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program.
FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.
FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with...
Federal Register notice: FDA proposes to revoke the routdated egulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Rep...
FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy for treating adul...
Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.
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 ...
