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 establishes a 15-percent improvement in an important endpoint compared to standard therapies. (7) The approval pathway established under this Act prohibits denial of coverage for any drug or biological product provisionally approved under this approval pathway on account of it being experimental. (8) Informed consent is required for any patients using a drug or biological product approved under the provisional approval pathway established under this Act. Any patients using a drug or biological product reviewed under this approval pathway must participate in an observational registry until those drugs or biological products receive full approval, with approval contingent on registry participation. (9) This Act requires that registries track aggregated, de-identified data that will be readily available to approved researchers for public health research purposes. (10) This Act creates, within the Office of the Commissioner at the FDA, the position of the Patient Advocate General to provide assistance to patients and their families utilizing drugs and biological products. 3. 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: 524B. 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 pathway for provisional approval within 90 days of receipt of a completed application. (2) Review of applications during epidemics and pandemics In the case of an epidemic or pandemic, including with respect to COVID–19, the Secretary shall accept and review various portions of an application