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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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Title 21
Chapter I
Part 99 - PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
Subpart A [§ 99.1 - § 99.3] - Subpart A—General Information
Subpart B [§ 99.101 - § 99.105] - Subpart B—Information To Be Disseminated
Subpart C [§ 99.201 - § 99.205] - Subpart C—Manufacturer's Submissions, Requests, and Applications
Subpart D [§ 99.301 - § 99.305] - Subpart D—FDA Action on Submissions, Requests, and Applications
Subpart E [§ 99.401 - § 99.405] - Subpart E—Corrective Actions and Cessation of Dissemination
Subpart F [§ 99.501 - § 99.501] - Subpart F—Recordkeeping and Reports
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