21 C.F.R. § 312.35 Submissions for treatment use.
Title 21 - Food and Drugs
(a) Treatment protocol submitted by IND sponsor. Any sponsor of a clinical investigation of a drug who intends to sponsor a treatment use for the drug shall submit to FDA a treatment protocol under §312.34 if the sponsor believes the criteria of §312.34 are satisfied. If a protocol is not submitted under §312.34, but FDA believes that the protocol should have been submitted under this section, FDA may deem the protocol to be submitted under §312.34. A treatment use under a treatment protocol may begin 30 days after FDA receives the protocol or on earlier notification by FDA that the treatment use described in the protocol may begin. (1) A treatment protocol is required to contain the following: (i) The intended use of the drug. (ii) An explanation of the rationale for use of the drug, including, as appropriate, either a list of what available regimens ordinarily should be tried before using the investigational drug or an explanation of why the use of the investigational drug is preferable to the use of available marketed treatments. (iii) A brief description of the criteria for patient selection. (iv) The method of administration of the drug and the dosages. (v) A description of clinical procedures, laboratory tests, or other measures to monitor the effects of the drug and to minimize risk. (2) A treatment protocol is to be supported by the following: (i) Informational brochure for supplying to each treating physician. (ii) The technical information that is relevant to safety and effectiveness of the drug for the intended treatment purpose. Information contained in the sponsor's IND may be incorporated by reference. (iii) A commitment by the sponsor to assure compliance of all participating investigators with the informed consent requirements of 21 CFR part 50. (3) A licensed practioner who receives an investigational drug for treatment use under a treatment protocol is an “investigator” under the protocol and is responsible for meeting all applicable investigator responsibilities under this part and 21 CFR parts 50 and 56. (b) Treatment IND submitted by licensed practitioner. (1) If a licensed medical practitioner wants to obtain an investigational drug subject to a controlled clinical trial for a treatment use, the practitioner should first attempt to obtain the drug from the sponsor of the controlled trial under a treatment protocol. If the sponsor of the controlled clinical investigation of the drug will not establish a treatment protocol for the drug under paragraph (a) of this section, the licensed medical practitioner may seek to obtain the drug from the sponsor and submit a treatment IND to FDA requesting authorization to use the investigational drug for treatment use. A treatment use under a treatment IND may begin 30 days after FDA receives the IND or on earlier notification by FDA that the treatment use under the IND may begin. A treatment IND is required to contain the following: (i) A cover sheet (Form FDA 1571) meeting §312.23(g)(1). (ii) Information (when not provided by the sponsor) on the drug's chemistry, manufacturing, and controls, and prior clinical and nonclinical experience with the drug submitted in accordance with §312.23. A sponsor of a clinical investigation subject to an IND who supplies an investigational drug to a licensed medical practitioner for purposes of a separate treatment clinical investigation shall be deemed to authorize the incorporation-by-reference of the technical information contained in the sponsor's IND into the medical practitioner's treatment IND. (iii) A statement of the steps taken by the practitioner to obtain the drug under a treatment protocol from the drug sponsor. (iv) A treatment protocol containing the same information listed in paragraph (a)(1) of this section. (v) A statement of the practitioner's qualifications to use the investigational drug for the intended treatment use. (vi) The practitioner's statement of familiarity with information on the drug's safety and effectiveness derived from previous clinical and nonclinical experience with the drug. (vii) Agreement to report to FDA safety information in accordance with §312.32. (2) A licensed practitioner who submits a treatment IND under this section is the sponsor-investigator for such IND and is responsible for meeting all applicable sponsor and investigator responsibilities under this part and 21 CFR parts 50 and 56. [52 FR 19477, May 22, 1987, as amended at 57 FR 13249, Apr. 15, 1992; 67 FR 9585, Mar. 4, 2002]
Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart B—Investigational New Drug Application (IND)
§ 312.35 Submissions for treatment use.
