The Knowledge Shelf

2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee

July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement

Discover FDA’s comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.

Clinical Outcome Assessments (COA) Qualification Program Submissions

Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program.

This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.

Information and resources for requestors about FDA’s Biomarker Qualification Program

FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first pro

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmeti

CDER Clinical Outcome Assessments (COA) Qualification Program: Frequently Asked Questions (FAQs)

Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs.

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 mil

The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.