Part 99 — Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.
Source: 63 FR 64581, Nov. 20, 1998, unless otherwise noted.
Sections
- § 99.1 Scope.
- § 99.3 Definitions.
- § 99.101 Information that may be disseminated.
- § 99.103 Mandatory statements and information.
- § 99.105 Recipients of information.
- § 99.201 Manufacturer's submission to the agency.
- § 99.203 Request to extend the time for completing planned studies.
- § 99.205 Application for exemption from the requirement to file a supplemental application.
- § 99.301 Agency action on a submission.
- § 99.303 Extension of time for completing planned studies.
- § 99.305 Exemption from the requirement to file a supplemental application.
- § 99.401 Corrective actions and cessation of dissemination of information.
- § 99.403 Termination of approvals of applications for exemption.
- § 99.405 Applicability of labeling, adulteration, and misbranding authority.
- § 99.501 Recordkeeping and reports.