Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 99—DISSEMINATION OF INFORMATION ON UNAPPRO...
PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
§ 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.