What 21 CFR Part 320 - Bioavailability and Bioequivalence Requirements (FDA) requires
FDA 21 CFR Part 320 sets the bioavailability and bioequivalence requirements for drug products, requiring applicants to submit the required data, apply the waiver criteria where appropriate, establish the basis for measuring in vivo…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-320
SHA-256 integrity: acd1ad6a2c7ecfa5ab9cc8c0ab18b43cb987f4a5b016455c94683f2b6f4c241e
Primary Citations — 17 traced to source
- 21 CFR § 320.1 - Definitions
- 21 CFR § 320.21 - Requirements for submission of bioavailability and bioequivalence data
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