1. Short title This Act may be cited as the Conditional Approval Act . 2. Conditional 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 the following: 524B. Conditional and time-limited approval pathway for new drugs (a) Pathway requirements The Secretary shall, at the request of the sponsor of a new drug, grant provisional and time-limited approval of such drug under this section, if the Secretary determines— (1) it is likely that the sponsor will be able to provide comprehensive clinical data after such drug is conditionally approved; (2) such drug is intended for the treatment, prevention, or medical diagnosis of a seriously debilitating disease, a life-threatening disease, or a chronic condition; (3) the expected benefits of the drug outweigh the potential risks to patients, taking into account the fact that additional data are still required to assess the drug and the severity of the underlying disease or condition the drug is intended to treat; (4) there are no existing meaningful treatments for the disease or condition that the drug is intended to treat; (5) confirmatory clinical trials are difficult or costly to conduct; and (6) such drug is intended to treat a disease or condition for which no more than 2 meaningful treatments currently exist. (b) Approval requirements (1) In general Not later than 180 days after the date on which the Secretary receives a request for conditional approval under subsection (a) with respect to a new drug, the Secretary shall require the sponsor of such drug to— (A) complete in a timely manner clinical investigations to provide full demonstration of safety and effectiveness as described under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, as applicable; (B) conduct clinical trials other than confirmatory trials, to demonstrate a certain degree of safety and efficacy of the drug