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Federal Register notice: FDA amends its regulations to require that certain data elements be submitted for veterinary devices that...[ Price : $8.95]
FDA extends by three months its review of an NDA for Biogens tofersen, an investigational new drug intended to treat superoxide di...[ Price : $8.95]
FDA revises two compliance programs on inspections effective 10/17 CP 7346.832 Preapproval Inspections and CP 7356.002 Drug GMP s...[ Price : $8.95]
Former FDA commissioners Mark McClellan and Scott Gottlieb say the recent user fee reauthorization was a profound missed opportuni...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Comparability Protocols for Postapproval Changes to the Che...[ Price : $8.95]
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...