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 adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.
21 CFR Part 312 · Investigational New Drug Application
§ 312.50 General responsibilities of sponsors
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 312.50
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Bioresearch Monitoring).
- General responsibilities of sponsors 195
- Ensuring compliance with plan and protocol 66
Warning letters citing § 312.50
3 FDA warning letters since 2017 cite this section :
- Amy Lightner, MD 25 Mar 2025
- Angela D. Ritter, M.D. 7 Jun 2024
- James R. Corbett, M.D. 27 Feb 2020
FDA guidance that cites § 312.50
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry 15 Dec 2025
- Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices draft 30 Dec 2024
- Conducting Clinical Trials With Decentralized Elements 18 Sept 2024
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry draft 18 Sept 2024
- Use of Data Monitoring Committees in Clinical Trials draft 13 Feb 2024
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies 21 Sept 2023
- A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry 12 Apr 2023
- Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors draft 30 Mar 2023
- Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry 1 Mar 2022
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry 1 Mar 2022
- Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials draft 9 Apr 2018
- Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for Industry 13 Dec 2016
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators draft 15 May 2015
- IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA Staff 1 Mar 2014
- Electronic Source Data in Clinical Investigations: Guidance for Industry 18 Sept 2013
and 7 more.
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 8831 19 Mar 1987