Title 21: Food and Drugs
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/ PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION
/ Subpart E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses / § 312.83 Treatment protocols.
§ 312.83 Treatment protocols.
If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in §§ 312.305 and 312.320. Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data necessary for a marketing application are being assembled by the sponsor and reviewed by FDA (unless grounds exist for clinical hold of ongoing protocols, as provided in § 312.42(b)(3)(ii)).