Incyte says its pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in certain patients with acute graft-vers...
FDA Review posts the Federal Register notices for the week ending 1/3/2020.
Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Special Protocol Assessment.
Cook Medical recalls its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge.
Federal Register notice: FDA seeks comments on an information collection revision for Imports and Electronic Import Entries.
Smiths Medical recalls its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption.
Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System.
Several stakeholders call on FDA to further clarify and explain its revised draft guidance on clinical decision support software.