Volume 7, Number 6—December 2001
Perspective
Developing New Smallpox Vaccines
Table A3
Issuance | Subject |
---|---|
21 CFR 50 | Protection of Human Subjects |
21 CFR 56 | Institutional Review Boards |
21 CFR 58 | Good Laboratory Practices |
21 CFR 210, 211 | Good Manufacturing Practices |
21 CFR 312 | Investigational New Drug Applications (INDs) |
21 CFR 314.126 | Adequate and Well-Controlled Studies |
21 CFR 610 | General Biological Product Standards |
21 CFR 610.12 | Sterility Testing |
21 CFR 610.13 | Purity Testing |
USP 24-(85) | Bacterial Endotoxin Test |
USP 24-(1510) | Pyrogen Test |
USP 24-(1171) | Sterility |
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