Former FDA commissioners Mark McClellan and Scott Gottlieb say the recent user fee reauthorization was a profound missed opportunity to reform FDA reg...
Federal Register notice: FDA makes available a final guidance entitled Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturin...
FDA releases a final guidance entitled ANDA Submissions Prior Approval Supplements (PAS) Under GDUFA.
FDA clears an Ulrich Medical 510(k) for its Flux-C 3D-printed porous titanium cervical interbody device.
Federal Register notice: FDA announces an opportunity for public comment on a statement of work to assess communication between FDA and sponsors throu...
Travere Therapeutics says it is expecting FDA to extend its review by three months of an accelerated approval-seeking NDA for sparsentan and its use i...
Revive Therapeutics finalizes an amended protocol for the companys Phase 3 clinical trial designed to evaluate the safety and efficacy of investigatio...
FDA accepts for review a BioMarin BLA resubmission for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A.
