Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices |
Subpart C - Manufacturer's Submissions, Requests, and Applications |
§ 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. |