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Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pi...[ Price : $8.95]
FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.[ Price : $8.95]
FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexametha...[ Price : $8.95]
Federal Register notice: FDA proposes to revoke the routdated egulations entitled Mutual Recognition of Pharmaceutical Good Manufa...[ Price : $8.95]
FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemothera...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Report...[ Price : $8.95]
Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors ...