CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for capturing post-approval s...
CDER's Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote presc...
CDRH launches a new Web page to discuss mission-critical priorities of data and technology innovations and provide information and resources on its Di...
FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease.
Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on ho...
FDA issues Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating c...
Federal Register notice: FDA establishes a docket to solicit comments on factors that should be considered when reviewing risk evaluation and mitigati...
An FDA advisory committee votes 9 to 0 that Biogens amyotrophic lateral sclerosis drug tofersen should be considered for accelerated approval.
