Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal...
FDA is joining with 16 other organizations to increase effective gene therapies for rare diseases.
CDER Office of Compliance director Don Ashley tells the Pharmaceutical Quality Symposium that during the Covid-10 pandemic, more than 70 bioresearch m...
FDA publishes two lists of final and draft guidance topics for FY 2022 and a list of final guidances from four years for comment on whether they shoul...
Five drug companies comment on an FDA draft guidance on a cancer antibody treatment dosing regimen.
Novartis says further evaluation of its lung cancer treatment canakinumab is warranted even though a Phase 3 trial did not meet its primary endpoints.
CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides says FDAs need to conduct preapproval inspections was reduced b...
Federal Register proposed order: FDA proposes to exempt certain blood and blood components for transfusion and cell and gene therapy products from ann...