C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart D—Responsibilities of Sponsors and Investigators

21 C.F.R. § 312.50

General responsibilities of sponsors

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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.

Notes of Decisions
Cited in 9 cases (1 in the last 5 years), 1990–2026 · leading case: Ferretti v. Pfizer Inc., 855 F. Supp. 2d 1017 (N.D. Cal. 2012).
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Ferretti v. Pfizer Inc., 855 F. Supp. 2d 1017 (N.D. Cal. 2012). · cites it 4× “Second, Plaintiff alleges that Defendant failed to disclose or report certain information related to the PanHER program, as required by 21 C.F.R. § 312.50 . This section requires a sponsor who intends to conduct a clinical investigation for a new drug (“sponsor”) to: “select[ ]…”
Suthers v. Amgen, Inc., 372 F. Supp. 2d 416 (S.D.N.Y. 2005). “One provision of the Common Rule, 21 C.F.R. § 50.25 (b)(2), anticipates that a study sponsor may seek the right to terminate a subject’s participation without his consent: When appropriate, one or more of the following elements of information shall also be provided to each…”
United States Ex Rel. Zissler v. Regents of the Univ., 992 F. Supp. 1097 (D. Minnesota 1998). “See 21 C.F.R. §§ 312.50 , 312.53; 42 C.F.R. § 52.”
Anderson v. Dep't of Health & Human Servs., 907 F.2d 936 (10th Cir. 1990). “§ 355 (i), 21 C.F.R. § 312.50 . Once the IND is approved by the FDA, the sponsor of the new drug can ship the drug for use in clinical tests, the results of which are reported to the FDA.”
In re Zofran (Ondansetron) Prods. Liab. Litig., 368 F. Supp. 3d 94 (D.D.C. 2019). “Harvey's report, other than citing to 21 C.F.R. § 312.50 (concerning the content and format of NDAs), simply states in general terms that "regulatory standards" required submission of the full reports, that the drug sponsor is "expected" to submit such reports, and that it is…”
Ben Wilkin v. Michael A. Narachi (Del. Ch. 2018). “§§ 355 , 355-1 and 21 C.F.R. § 312.50 in his Answering Brief.”
Spedale v. Constellation Pharm. Inc. (D. Ariz. 2019). “(DSOF ¶ 19 (citing 21 C.F.R. § 312.50 ); PSOF ¶ 19.) 24 10 At MGH, a leukemia patient presented with “confusion,” which later resolved (MGH’s principal investigator deemed the patient’s confusion unrelated to the study drug).”
Alzamend Neuro, Inc. v. Biorasi, LLC (S.D. Fla. 2026). “As to Biorasi’s regulatory and statutory obligations, Alzamend cites no case law to support its claim that 21 C.F.R. § 312.50 or § 312.57 create an assumed duty of care.”
Darke ex rel. Est. of Darke v. Est. of Isner, 20 Mass. L. Rptr. 419 (Mass. Super. Ct. 2005). “21 C.F.R. §312.50 . In essence, VGI supervised the implementation of the study.”
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