C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 601—LICENSING › Subpart F—Confidentiality of Information

21 C.F.R. § 601.50

Confidentiality of data and information in an investigational new drug notice for a biological product

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(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.

[39 FR 44656, Dec. 24, 1974]
Notes of Decisions
Cited in 1 case, 2020–2020 · leading case: Goldwater Inst. v. Hhs (9th Cir. 2020).
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Goldwater Inst. v. Hhs (9th Cir. 2020). “, 21 C.F.R. §§ 601.50 (providing, in part, that the existence of an IND notice will not be disclosed unless previously publicly disclosed), 601.”
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