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 B—Investigational New Drug Application (IND)

21 C.F.R. § 312.33

Annual reports

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A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:

(a) Individual study information. A brief summary of the status of each study in progress and each study completed during the previous year. The summary is required to include the following information for each study:

(1) The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population, and a statement as to whether the study is completed.

(2) The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, gender, and race; the number whose participation in the study was completed as planned; and the number who dropped out of the study for any reason.

(3) If the study has been completed, or if interim results are known, a brief description of any available study results.

(b) Summary information. Information obtained during the previous year's clinical and nonclinical investigations, including:

(1) A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system.

(2) A summary of all IND safety reports submitted during the past year.

(3) A list of subjects who died during participation in the investigation, with the cause of death for each subject.

(4) A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related.

(5) A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, information from controlled trials, and information about bioavailability.

(6) A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings.

(7) A summary of any significant manufacturing or microbiological changes made during the past year.

(c) A description of the general investigational plan for the coming year to replace that submitted 1 year earlier. The general investigational plan shall contain the information required under § 312.23(a)(3)(iv).

(d) If the investigator brochure has been revised, a description of the revision and a copy of the new brochure.

(e) A description of any significant Phase 1 protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment.

(f) A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country.

(g) If desired by the sponsor, a log of any outstanding business with respect to the IND for which the sponsor requests or expects a reply, comment, or meeting.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 63 FR 6862, Feb. 11, 1998; 67 FR 9585, Mar. 4, 2002]
Notes of Decisions
Cited in 3 cases (1 in the last 5 years), 2017–2021 · leading case: Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017).
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Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017). · cites it 2× “See 21 C.F.R. § 312.33 (b)(1) (stating that developers, in their annual reports to the FDA, must disclose summary information “showing the most frequent and the most serious” adverse events observed during that year’s clinical and nonelinical drug investigations).”
In re Zofran (Ondansetron) Prods. Liab. Litig., 368 F. Supp. 3d 94 (D.D.C. 2019). · cites it 2× “The Annual Report, submitted to the FDA pursuant to 21 C.F.R. § 312.33 , provided the name and study number for each of the three studies, among other reproduction studies conducted on Zofran in Japan.”
Leclair v. GlaxoSmithKline LLC (D. Mass. 2021). “The Annual Report, submitted to the FDA pursuant to 21 C.F.R. § 312.33 , 13 Study No. 100423 was not included, as it was a preliminary study conducted “[t]o establish the dose levels” for the definitive Study No.”
— 21 C.F.R. § 312.33(b)(1) — 1 case
Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017). “See 21 C.F.R. § 312.33 (b)(1) (stating that developers, in their annual reports to the FDA, must disclose summary information “showing the most frequent and the most serious” adverse events observed during that year’s clinical and nonelinical drug investigations).”
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