Manual of Standard Operating Procedures and Policies
Regulatory - License Applications
Complete Review and Issuance of Action Letters
SOPP 8405 |
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Version #4 |
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Date: Sep. 20, 2004 |
Appendix 1. Signature Authority for Action Letters
Office of Blood Research and Review
Signature authority for:
- Approval letters for applications representing novel products is delegated to the Office Director
- Approval letters for applications for products that are the same, or similar to, previously licensed products (not novel) is delegated to Division Director with product responsibility
- Approval letters for supplements is delegated to the Division Director with product responsibility
- Complete Response letters for applications and for supplements is delegated to the Division Director with product responsibility.
Office of Cellular, Tissue and Gene Therapy
Signature authority for:
- Approval letters for applications is delegated to the Office Director
- Approval letters for supplements is delegated to the Division Director with product responsibility, or, if clinical, to the Director of the Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT)
- Complete Response letters for applications is delegated jointly to the Division Director with product responsibility and the Director, DCEPT
- Complete Response letters for supplements is delegated to the Division Director with product responsibility, or, if clinical, the Director, DCEPT.
Office of Vaccines Research and Review
Signature authority for:
- Approval letters for new applications is delegated to the Office Director
- Approval letters for supplements is delegated to the Division Director with product responsibility or, in the case of clinical efficacy supplements, to the Director, Division of Vaccines and Related Products Applications (DVRPA)
- Complete Response letters for applications and for supplements is delegated to the Division Director with product responsibility or, in the case of clinical efficacy supplements, to the Director, DVRPA.
Office of Compliance and Biologics Quality
Signature authority for:
- Approval letters for applications that include a new license number and prior approval supplements is delegated to the Office Director
- Approval letters for CBE and CBE-30 supplements is delegated to the Director, Division of Manufacturing and Product Quality
- Complete Response letters for all supplements is delegated to the Director, Division of Manufacturing and Product Quality.
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