21 CFR Part 99
PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
- PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- Subpart A—General Information
- § 99.1 Scope.
- § 99.3 Definitions.
- Subpart B—Information To Be Disseminated
- § 99.101 Information that may be disseminated.
- § 99.103 Mandatory statements and information.
- § 99.105 Recipients of information.
- Subpart C—Manufacturer's Submissions, Requests, and Applications
- § 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.
- Subpart D—FDA Action on Submissions, Requests, and Applications
- § 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.
- Subpart E—Corrective Actions and Cessation of Dissemination
- § 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.
- Subpart F—Recordkeeping and Reports
- § 99.501 Recordkeeping and reports.
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