; and (C) demonstrate that necessary post-market surveillance and risk-management tools are in place with respect to the drug. (2) Period of conditional approval The period of conditional approval for a drug under this subsection is effective for 1 year, and is renewable by the Secretary for up to 4 additional 1-year terms. A conditional approval shall be in effect for not more than 5 years from the date on which conditional approval is first granted. (3) Time limitation If any conditionally drug approved under this section is not brought to market within 3 years of the conditional approval, any conditional approval granted under this section with respect to such drug shall be deemed invalid. (4) Requirements As a condition on receipt of conditional approval under this section, the Secretary shall require the sponsor of the drug to agree to the following: (A) Complete in a timely manner such clinical investigations to provide a full demonstration of effectiveness as the Secretary determines to be necessary for approval of the drug under section 505 of this Act or section 351 of the Public Health Service Act, as applicable. (B) Submit to the Secretary an annual report on the progress of the sponsor in conducting the clinical investigations required under this section. (C) Ensure that all labeling and promotional materials for the drug bear the statement conditionally approved by the FDA pending a full demonstration of effectiveness under applicable ___ (specifying the application number assigned by the Secretary in place of the blank). (5) Applying for full approval The sponsor of a drug granted conditional approval pursuant to this subsection may, at any point, submit an application for full approval as described under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, as applicable. (6) Utilization of real world evidence to support full approval The Secretary shall allow the use of real world evidence, as defined in section 505F(b), and collected by the