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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
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| 99-1 | Scope. | ||
| 99-3 | Definitions. | ||
| 99-101 | Information that may be disseminated. | ||
| 99-103 | Mandatory statements and information. | ||
| 99-105 | Recipients of information. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| 99-501 | Recordkeeping and reports. | ||