FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

On 20 June, the U.S. Food and Drug Administartion has updated their page about "Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases". On this page the FDA gives an overview about:

Licensed Donor Screening Tests
Cleared Nucleic Acid Tests (NAT) for Chlamydia trachomatis and Neisseria gonorrhea
Cleared Donor Screening Tests for Cytomegalovirus (CMV)
Cleared Tests for Syphilis

Furthermore they refer to other relevant guidelines and documents:

Additional Resources

Tissue Safety & Availability
Tissue & Tissue Products
Cellular & Gene Therapy Products

Information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under 1271.80:

Testing HCT/P Donors: Specific Requirements
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (8/8/2007)
Blood Donor Screening Tests