FDA sends an email to Praxis Precision Medicines that placed a clinical hold on PRAX-222, an antisense oligonucleotide for treating patients with SCN2A gain-of-function epilepsy.
FDA warns healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device System and appear to present with pump thrombosis may instead have a welding defect in the device.
CDER’s Office of Compliance (OC) says its priorities for 2022 include supporting FDA’s Covid-19 response , reducing harm caused by opioid crisis, and improving the agency’s oversight of drug compounding operations.
FDA lifts a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical development for preventing recurrent C. difficile infection.
FDA announces the tentative Vaccines and Related Biological Products Advisory Committee schedule that has five separate dates the panel will meet to review and discuss emergency use authorization submissions for Covid-19 vaccines.
Federal Register notice: FDA determines that Abraxis Pharmaceutical’s cupric sulfate injection was not withdrawn from sale for reasons of safety or effectiveness.