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

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

Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Learn more.

CGMP/Finished Pharmaceuticals/Adulterated

The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller