1. Short title This Act may be cited as the Promising Pathway Act . 2. Findings Congress finds as follows: (1) The drugs and biological products intended to be reviewed under the pathway established under this Act are for the treatment and prevention of serious diseases or conditions, especially those for which there are no available on-label meaningful or disease-modifying treatments, where speed to access is critical. (2) The approval pathway established under this Act is intended to allow drug and biological product applications to be more rapidly reviewed by the U.S. Food and Drug Administration (FDA), with the FDA reviewing various portions of new drug and biological product applications as they become available. (3) The approval pathway established under this Act establishes a clear approval pathway that can be utilized by sponsors to receive rolling review of applications for drugs and biological products intended to treat serious diseases, including drugs and biological products intended to treat COVID–19 that reduce the risk of death, severe disease, and progression of symptoms in those exposed to the virus. (4) The approval pathway established under this Act will enable sponsors to receive early, time-limited, and provisional approval for drugs and biological products that have demonstrated substantial evidence of safety and relevant early evidence that establishes that the drug provides a positive therapeutic outcome. (5) The approval pathway established under this Act will allow for the use of real-world evidence and scientifically substantiated surrogates, other than those previously validated by the FDA, to predict the clinical benefits and ultimately support provisional approval. (6) Drugs and biological products granted provisional approval under the pathway established under this Act are limited to a 2-year approval period, renewable every 2 years, for up to 6 years. Full approval can awarded at any time, for any drug or biological product provisionally approved under this pathway that