Attorney Bradley Thompson urges the medical device industry to weigh the downstream consequences of unbridled enthusiasm for FDAs proposed software pr...
FDA approves a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia.
FDA releases its latest batch of Warning Letters that includes Biotek Inc. and Dexcowin Co.
FDA says AuroMedics recalled two lots of ampicillin and sulbactam for injection due to complaints that it contained red particulate matter.
In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood hints that the agency is working on a guidance on manufacture...
Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities.
Federal Register notice: FDA withdraws a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection require...
FDA permits the de novo marketing of Wilson-Cook Medicals Hemospray, a new device used to help control certain types of bleeding in the gastrointestin...