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 5 - Organization |
Subpart C - Human Drugs; Redelegations of Authority |
§ 5.100 - Issuance of notices implementing the provisions of the Drug Amendments of 1962. |
§ 5.101 - Termination of exemptions for new drugs for investigational use in human beings. |
§ 5.102 - Authority to approve and to withdraw approval of a charge for investigational new drugs. |
§ 5.103 - Approval of new drug applications and their supplements. |
§ 5.104 - Responses to Drug Enforcement Administration temporary scheduling notices. |
§ 5.105 - Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements. |
§ 5.106 - Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. |
§ 5.107 - Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs. |
§ 5.108 - Authority relating to waivers or reductions of prescription drug user fees. |
§ 5.109 - Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs. |
§ 5.205 - Chief Counsel, Food and Drug Administration. |
§ 5.210 - FDA Public Information Offices. |
§ 5.215 - Field structure. |