FDA grants Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respiratory tract disease.
FDA gives Regenerative Medicine Advanced Therapy designation to a University of California San Francisco gene therapy treatment for Artemis-SCID disea...
Federal Register notice: FDA announces a 3/10 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear an overview of research programs...
Federal Register notice: FDA seeks industry organizations to help in selecting voting industry representatives to serve on CDRHs Technical Electronic ...
Two Dechert attorneys say businesses accounting for off-label uses of a drug or medical device when deciding how much to produce need not run afoul of...
Federal Register notice: CDER and CBER annouces that 2/15 is the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards...
A Medill News Service report says part of the upcoming PDUFA reauthorization could be a Rare Disease Endpoint Advancement pilot program.
Three stakeholders comment on an FDA draft guidance on visual inspection of injectable products for visible particulates.