§312.84. Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. — Inbound Citations

(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.