FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...
The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual drug compounding listen...
FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood ...
Federal Register notice: FDA publishes a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices und...
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.
