CFR section
21 CFR 312.50: General responsibilities of sponsors
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.50 |
|---|---|
| Section | General responsibilities of sponsors |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.