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FDA releases a final guidance entitled ANDA Submissions Prior Approval Supplements (PAS) Under GDUFA.[ Price : $8.95]
FDA clears an Ulrich Medical 510(k) for its Flux-C 3D-printed porous titanium cervical interbody device.[ Price : $8.95]
Federal Register notice: FDA announces an opportunity for public comment on a statement of work to assess communication between FD...[ Price : $8.95]
Travere Therapeutics says it is expecting FDA to extend its review by three months of an accelerated approval-seeking NDA for spar...[ Price : $8.95]
Revive Therapeutics finalizes an amended protocol for the companys Phase 3 clinical trial designed to evaluate the safety and effi...[ Price : $8.95]
FDA accepts for review a BioMarin BLA resubmission for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A...[ Price : $8.95]
Federal Register notice: FDA seeks consumer organizations that are interested in participating in selecting voting and nonvoting c...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practice in...