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21 C.F.R. PART 99--DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A--GENERAL

PART 99--DISSEMINATION 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.