§312.86. Focused FDA regulatory research. — Inbound Citations
21 C.F.R. § 312.86
Statutory Authority
Cited by 1 regulation in release 2026-08-27.
Citations to 21 C.F.R. § 312.86 as a whole
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(c) For drugs intended to treat life-threatening or severely-debilitating illnesses that are developed in accordance with §§ 312.80 through 312.88 of this chapter, the criteria contained in paragraphs (b) (3), (4), and (5) of this section shall be applied according to the considerations contained in § 312.84 of this chapter.