FDA approves a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt) for treating anemia after failing an erythropoiesis stim...
Former FDA commissioner Scott Gottlieb weighs in on hydroxychloroquine for treating coronavirus and what he sees as the better potential of antiviral ...
A new Government Accountability Act report examines 637 NDAs submitted between 2014 to 2018 and found that review times were mainly driven by the char...
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on...
Federal Register notice: FDA sends to OMB an information collection extension for Human Cells, Tissues, and Cellular and Tissue-Based Products: Establ...
Federal Register notice: FDA reschedules for 5/5 its public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.
As CDRH focuses on coronavirus-related activities, the Center extends its reliance on teleconferences in lieu of in-person meetings with industry.
FDA posts a final guidance entitled Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Covid-19) Public Health...