Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global Annual Meeting in Phil...
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for first-in-human clin...
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, ...
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework in...
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...
An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arg...
Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children and adolescents age...
FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for pheny...
