Federal Register notice: FDA announces an 11/4 Blood Products Advisory Committee meeting that will hear CBER research updates.
Federal Register notice: FDA consolidates regulatory oversight responsibilities in CBER for certain devices, and accordingly fat transfer devices with...
FDA posts a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gene Therapy Products I...
FDA classifies as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company (XXX SUBSTITUTE XXX) due to ...
FDA accepts for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced ...
FDA Review posts the Federal Register notices for the week ending 9/10/2021.
FDA Review posts product approval summaries for the week ending 9/13/2021.
Federal Register notice: FDA announces a 10/28 Allergenic Products Advisory Committee meeting that will hear an overview of certain research programs ...