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Volume 7, Number 6—December 2001


Developing New Smallpox Vaccines

Steven R. RosenthalComments to Author , Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
Author affiliations: Food and Drug Administration, Rockville, Maryland, USA

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Table A3

U.S. Code of Federal Regulations (CFR) and US Pharmacopeia (USP) Standards Applicable to Vaccines

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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