§ 312.83. Treatment protocols.
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/us/cfr/t21/s§ 312.83·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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)). [53 FR 41523, Oct. 21, 1988, as amended at 76 FR 13880, Mar. 15, 2011]
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§ 312.83
Treatment protocols.
Fed. Reg.×4
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