Human Drugs
Vanda Sues FDA Over Drug Review Documents
Vanda Pharmaceuticals files a lawsuit to compel FDA to produce drug review records associated with the companys supplemental NDA for Hetlioz (tasimelt...
Human Drugs
Clinical Hold Lifted on Gileads Magrolimab
FDA lifts a Gilead Sciences partial clinical hold on studies evaluating its investigational agent magrolimab in combination with azacytidine in myelod...
Federal Register
Latest Federal Register Notices
FDA Review posts the latest Federal Register notices for the week ending 4/8/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/8/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
2 Device Guides on Performance Criteria
Federal Register notice: FDA makes available two medical device guidance documents for the Safety and Performance Based Pathway.
Federal Register
Final Guide on ICH Drug Study Considerations
Federal Register notice: FDA makes available a final guidance entitled E8(R1) General Considerations for Clinical Studies.
Federal Register
Pediatric Oncology Meeting on Study Waivers
Federal Register notice: FDA announces a 5/11-12 Pediatric Oncology Subcommittee meeting to discuss FDA decisions on sponsor plans and requests for wa...
Medical Devices
Medtronic MiniMed Recall Due to Labeling Design
Medtronic recalls certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error that could cause the devices to not deliver basal ...
Bausch Hit With OPDP Letter on Duobrii
CDERs Office of Prescription Drug Promotion issues Bausch Health Companies an untitled letter that cited the firm over its promotional communications,...
