CFR Title 21 Part 600 addresses general biological good manufacturing practices. This is where a transfusion services laboratory can locate the addresses for notifications if and when needed, including the addresses for:
- Center for Biologics Evaluation and Research (CBER)
- Adverse experience reports
- Biological product deviation reports
- Fatality reports
- Center for Drug Evaluation and Research (CDER)
- Licensed products regulated by CDER (drugs)
- Post-marketing adverse experience reporting
Definitions for the terms that are used in Part 600 are also included at the beginning of the section.
