A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...
In July 2025, the US Food and Drug Administration (FDA) announced a pilot program intended to expedite reviews for drug applications that met one of five national priorities, including products deemed ...