21 C.F.R. § 312.83 Treatment protocols.
Title 21 - Food and Drugs
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 §§312.34 and 312.35. 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)).
Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
§ 312.83 Treatment protocols.
