Code of Federal Regulations · Section
§ 312.83 — Treatment Protocols
21 C.F.R. § 312.83
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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)).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351
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Regulation of biological products42 U.S.C. § 262
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Definitions; generally21 U.S.C. § 321