Title 21, Part 99 — Dissemination of Information on Unapproved/new Uses for Marketed Drugs, Biologics, and Devices
15 sections
Section 99.1
Scope.
Section 99.3
Definitions.
Section 99.101
Information that may be disseminated.
Section 99.103
Mandatory statements and information.
Section 99.105
Recipients of information.
Section 99.201
Manufacturer's submission to the agency.
Section 99.203
Request to extend the time for completing planned studies.
Section 99.205
Application for exemption from the requirement to file a supplemental application.
Section 99.301
Agency action on a submission.
Section 99.303
Extension of time for completing planned studies.
Section 99.305
Exemption from the requirement to file a supplemental application.
Section 99.401
Corrective actions and cessation of dissemination of information.
Section 99.403
Termination of approvals of applications for exemption.
Section 99.405
Applicability of labeling, adulteration, and misbranding authority.
Section 99.501
Recordkeeping and reports.