1. Short title This Act may be cited as the Promising Pathway Act . 2. Provisional approval of new human drugs (a) In general Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end of the following: 524C. Provisional approval of new human drugs (a) Priority review and evaluation of applications (1) In general The Secretary shall establish a priority review system to evaluate applications submitted under this section for provisional approval within 90 days of receipt of a completed application. (2) Other designations If a drug submitted for review under this section is eligible for a special designation by the Secretary under this Act, including as a drug for a rare disease or condition under section 526, all benefits of such other designation shall be available for use under provisional approval, including any tax credits and waiving of fees under chapter VII. (b) Eligibility A drug may be eligible for provisional approval under this section if the Secretary determines that the drug is intended for the treatment, prevention, or medical diagnosis of a serious or life-threatening disease or condition for which there is a reasonable likelihood that premature death will occur without early medical intervention for an individual contracting or being diagnosed with such disease or condition. (c) Standard of review for provisional approval (1) Requirements An application for provisional approval under this section may be approved only if the Secretary determines that— (A) there is substantial evidence of safety for the drug, such that there is evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the safety of the drug involved, on the basis of which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or