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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 601Subpart F - Subpart F—Confidentiality of Information
§ 601.50 - Confidentiality of data and information in an investigational new drug notice for a biological product.
§ 601.51 - Confidentiality of data and information in applications for biologics licenses.
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