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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 29, 2014

Title 21Chapter ISubchapter APart 99


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

rule

Subpart A—GENERAL INFORMATION

§99.1
Scope.
§99.3
Definitions.
rule

Subpart B—INFORMATION TO BE DISSEMINATED

§99.101
Information that may be disseminated.
§99.103
Mandatory statements and information.
§99.105
Recipients of information.
rule

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.
rule

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.
rule

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.
rule

Subpart F—RECORDKEEPING AND REPORTS

§99.501
Recordkeeping and reports.


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