Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links

-

Vaccines, Blood & Biologics

-

Section 9150: Office of Cellular, Tissue and Gene Therapies

-

SOPP 9150.1: Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of Changes in a Gene Therapy Protocol
Effective Date: October 1, 2002
SOPP 9150.2: Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of FDA's Receipt of Adverse Event Reports to Gene Therapy INDs
Effective Date: October 1, 2002
SOPP 9151: Procedures for Handling Requests for Exemptions and Alternative Procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Under 21 CFR Section 1271.155
Effective Date: June 13, 2006

-

-

-

-

-

-