Drug Development Tool Qualification Process: Transparency Provisions

Under the 21st Century Cures Act enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools was added to the Federal Food, Drug, and Cosmetic Act and formally establishes an updated, multi-stage process for DDT qualification. This process includes three submission milestones and transparency provisions that address requestors ’ submissions and FDA’s formal written determinations in response to such submissions. The transparency provisions of section 507 will apply only to submissions (LOIs, QP, and FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted).

Source: FDA Center for Drug Evaluation and Research - What's New - July 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news