Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 99: Dissemination Of Information On Unapproved/New Uses For Marketed Drugs, Biologics, And Devices

Section No. Description
Section 99.1 Definitions
Section 99.3 Information that may be disseminated
Section 99.101 Mandatory statements and information
Section 99.103 Recipients of information
Section 99.105 Manufacturer's submission to the agency
Section 99.201 Request to extend the time for completing planned studies
Section 99.203 Application for exemption from the requirement to file a supplemental application
Section 99.205 Agency action on a submission
Section 99.301 Extension of time for completing planned studies
Section 99.303 Exemption from the requirement to file a supplemental application
Section 99.305 Corrective actions and cessation of dissemination of information
Section 99.401 Termination of approvals of applications for exemption
Section 99.403 Applicability of labeling, adulteration, and misbranding authority
Section 99.405 Recordkeeping and reports
Section 99.501 Petitions requesting exemption from preemption for State or local requirements