Pharmacovigilance – Code of Federal Regulation

eCFR :: 21 CFR 600.80 — Postmarketing reporting of adverse experiences.

Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services
Subchapter F —Biologics
Part 600 —Biological Products: General
Subpart D —Reporting of Adverse Experiences
Source: 59 FR 54042, Oct. 27, 1994, unless otherwise noted.
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264.
§ 600.80 Postmarketing reporting of adverse experiences.
This content is from the eCFR and is authoritative but unofficial.
(a) Definitions. The following definitions of terms apply to this section:
Adverse experience. Any adverse event associated….. (see link or attached PDF for details)