[ Price : $8.95]
Writing in a 5/2 online JAMA viewpoint, senior FDA officials prepare the agency and the public to accept that Covid-19 infections ...[ Price : $8.95]
Federal Register notice: FDA announces a 6/17 Psychopharmacologic Drugs Advisory Committee meeting to vote on an Acadia Pharmaceut...[ Price : $8.95]
FDA warns the Oxford, OH-based Miami University Department of Chemistry and Biochemistry contract testing laboratory about CGMP de...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Detention and Banned Medical...[ Price : $8.95]
Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.[ Price : $8.95]
FDA removes a clinical hold on Pfizers giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing...[ Price : $8.95]
FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan ...[ Price : $8.95]
Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.