21 CFR § 514.12
Confidentiality of data and information in an investigational new animal drug notice
June 25, 2020
(a) The existence of an INAD notice 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 INAD file shall be handled in accordance with provisions established in §514.11.
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