21 CFR 601.50
§ 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 601.50, § 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88349
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Full text
(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.
(b) The availability for public disclosure of all data and information in an IND file for a biological product shall be handled in accordance with the provisions established in § 601.51.
(c) Notwithstanding the provisions of § 601.51, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational biological product has been used a copy of any adverse reaction report relating to such use.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.