Title 21

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 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.

• 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.

21:1.0.1.1.34.1	SUBPART A	Subpart A - General Information
21:1.0.1.1.34.1.63.1	SECTION 99.1	99.1 Scope.
21:1.0.1.1.34.1.63.2	SECTION 99.3	99.3 Definitions.
21:1.0.1.1.34.2	SUBPART B	Subpart B - Information To Be Disseminated
21:1.0.1.1.34.2.63.1	SECTION 99.101	99.101 Information that may be disseminated.
21:1.0.1.1.34.2.63.2	SECTION 99.103	99.103 Mandatory statements and information.
21:1.0.1.1.34.2.63.3	SECTION 99.105	99.105 Recipients of information.
21:1.0.1.1.34.3	SUBPART C	Subpart C - Manufacturer's Submissions, Requests, and Applications
21:1.0.1.1.34.3.63.1	SECTION 99.201	99.201 Manufacturer's submission to the agency.
21:1.0.1.1.34.3.63.2	SECTION 99.203	99.203 Request to extend the time for completing planned studies.
21:1.0.1.1.34.3.63.3	SECTION 99.205	99.205 Application for exemption from the requirement to file a supplemental application.
21:1.0.1.1.34.4	SUBPART D	Subpart D - FDA Action on Submissions, Requests, and Applications
21:1.0.1.1.34.4.63.1	SECTION 99.301	99.301 Agency action on a submission.
21:1.0.1.1.34.4.63.2	SECTION 99.303	99.303 Extension of time for completing planned studies.
21:1.0.1.1.34.4.63.3	SECTION 99.305	99.305 Exemption from the requirement to file a supplemental application.
21:1.0.1.1.34.5	SUBPART E	Subpart E - Corrective Actions and Cessation of Dissemination
21:1.0.1.1.34.5.63.1	SECTION 99.401	99.401 Corrective actions and cessation of dissemination of information.
21:1.0.1.1.34.5.63.2	SECTION 99.403	99.403 Termination of approvals of applications for exemption.
21:1.0.1.1.34.5.63.3	SECTION 99.405	99.405 Applicability of labeling, adulteration, and misbranding authority.
21:1.0.1.1.34.6	SUBPART F	Subpart F - Recordkeeping and Reports
21:1.0.1.1.34.6.63.1	SECTION 99.501	99.501 Recordkeeping and reports.

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