Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
AdvaMed calls for updates to FDA and HHS informed consent guidances.
FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...
Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Processes for Advisory Com...
FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.
BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic in two wells.
Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Materials and Component...
