FDA chief of staff Julie Tierney says the agency is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health...
Abiomed recalls its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the devices purge sidearm.
FDA issues a Dear Doctor letter about supply constraints involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S.
FDA removes a partial clinical hold against Foghorn Therapeutics Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia an...
Draeger Medical recalls its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit can become loose.
FDA places an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations docum...
FDA extends by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors.
FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.
