Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
Federal Register notice: FDA makes available a draft guidance entitled Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pendin...
FDA approves Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin) 10 mg tablets for treating certain patients with chronic kidney disease.
Senators Edward Markey (D-MA) and Joe Manchin (D-WV) call on FDA to curb the use of enriched enrollment randomized withdrawal studies to support opioi...
U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical device recall process.
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics implantable ITCA 650 (exenatide in DU...
FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs regulated by CDER a...
FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs, and their supplemen...
