Federal Register notice: FDA sends to OMB an information collection extension entitled Generic Clearance for Quantitative Testing for the Development ...
The House Energy and Commerce Committees Health Subcommittee announces a 2/3 user fee reauthorization hearing that will review FDA/industry agreements...
Federal Register notice: FDA seeks comments on an information collection extension entitled Export of Medical Devices; Foreign Letters of Approval.
Federal Register notice: FDA is announcing the availability of its annual compilation of update notices related to the agencys Susceptibility Test Int...
Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus eryth...
Joining Incyte in withdrawing an NDA over a confirmatory study disagreement, Regeneron Pharmaceuticals and Sanofi withdraw their supplemental BLA for ...
FDA commissioner nominee Robert Califfs chances of passing a Senate vote narrow as he reportedly loses some Senate backing and the White House has bee...
Federal Register notice: FDA makes available a draft guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeling.