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Part 99
FEDERAL · 21 CFR
Part 99 — Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
15 sections · Title 21: Food and Drugs
§ 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.