What 21 CFR Part 600 - FDA Biological Products: General Standards, Records and Reporting requires
21 CFR Part 600 sets the general standards applicable to licensed biological products regulated by the U.S. Food and Drug Administration through the Center for Biologics Evaluation and Research…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600
SHA-256 integrity: 17782b34eb61876aebdc287a8387b0d1ec1cd484e3f1875dfe2905196da333f8
Primary Citations — 9 traced to source
- Public Health Service Act, 42 U.S.C. 262, and Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq. - statutory authority
- 21 CFR Part 600, § 600.10 - personnel
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