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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
 

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.

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.

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