[ Price : $8.95]
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...[ Price : $8.95]
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about...[ Price : $8.95]
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.[ Price : $8.95]
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...[ Price : $8.95]
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...[ Price : $8.95]
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, ...[ Price : $8.95]
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting ...