§312.2. Applicability. — Inbound Citations
21 C.F.R. § 312.2
Statutory Authority
Cited by 2 regulations in release 2026-08-27.
Citations to §312.2(a)
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(a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).
Citations to §312.2(b)(2)(ii)
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(ii) A person may ship a biological product for investigational in vitro diagnostic use that is listed in § 312.2(b)(2)(ii) if it is labeled as follows: