An Oklahoma federal court grants a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three company officials that requ...
Federal Register notice: FDA sends to OMB an information collection revision for Human Drug Compounding Under Sections 503A and 503B of the Federal Fo...
FDA updates a guidance to explain how sterile compounded drugs can be prepared in a segregated compounding area if standard personal protective equipm...
FDA posts a Web resource page on using thermal imaging systems for temperature screening during Covid-19.
FDA warns Ideal Implants about QS and MDR violations in its manufacturing of saline-filled breast implants.
FDA warns Allergan that it is not complying with post-approval study requirements for two styles of silicone breast implants.
Federal Register notice: FDA withdraws approval of 16 NDAs from multiple applicants after they notified the agency that the drug products were no long...
Zealand Pharma submits an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia.