Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 8, 2016
February 3, 2025
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