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. § 312.55

Informing investigators

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(a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).

(b) The sponsor shall, as the overall investigation proceeds, keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised investigator brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with § 312.32.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]
Notes of Decisions
Cited in 2 cases, 2012–2019 · 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 2× “” Finally, under 21 C.F.R. § 312.55 , a sponsor has a responsibility to give “each participating clinical investigator an investigator brochure containing the information described in § 312.”
Spedale v. Constellation Pharm. Inc. (D. Ariz. 2019). “at 12–13); see also 21 C.F.R. § 312.55 26 (imposing duties on sponsors, distinct from those imposed on investigators, to provide 27 information required to draft proper ICFs); Butler v.”
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