---
kind: "section"
citation: "21 C.F.R. § 601.50"
title: "21"
number: "601.50"
heading: "Confidentiality of data and information in an investigational new drug notice for a biological product."
url: "https://uscodex.org/cfr/21/601.50"
---

# §601.50. Confidentiality of data and information in an investigational new drug notice for a biological product.

- (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](/cfr/21/601.51.md).
- (c) Notwithstanding the provisions of [§ 601.51](/cfr/21/601.51.md), 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.

## Notes

### Amendments

[39 FR 44656, Dec. 24, 1974]

### Authority

Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.

### Source

Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

### Amendments

[39 FR 44656, Dec. 24, 1974]