COA Qualification Prog FAQs

Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program InformationCOA Qualification Considerations and RequirementsCOA Development and...

Cellular and Gene Therapy Guidances

Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA. Frequently Asked...