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Title 21 - Title 21

Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

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GENERAL - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

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15 sections

§99.1 - Scope.

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§99.101 - Information that may be disseminated.

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§99.103 - Mandatory statements and information.

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§99.105 - Recipients of information.

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§99.201 - Manufacturer's submission to the agency.

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§99.203 - Request to extend the time for completing planned studies.

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§99.205 - Application for exemption from the requirement to file a supplemental application.

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§99.3 - Definitions.

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§99.301 - Agency action on a submission.

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§99.303 - Extension of time for completing planned studies.

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§99.305 - Exemption from the requirement to file a supplemental application.

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§99.401 - Corrective actions and cessation of dissemination of information.

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§99.403 - Termination of approvals of applications for exemption.

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§99.405 - Applicability of labeling, adulteration, and misbranding authority.

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§99.501 - Recordkeeping and reports.

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