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FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs regulated by CDER a...
FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs, and their supplemen...
Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a sNDA next year that ...
Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device biocompatibility.
An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide drugs such as Ozempic.
