Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for first-in-human clin...
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, ...
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework in...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...
Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene ...
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...
