2004 CFR Title 21, Volume 1

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
	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.