lower prices for patients. (9) Establishing a clear timeframe for the Food and Drug Administration to expedite the review of certain applications for generic drugs would also help keep drug prices down and improve timely access for patients. I Removing regulatory barriers to competition 101. Improving generic access Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is amended by adding at the end the following: (11) (A) The Secretary shall prioritize the review, and act not later than 180 calendar days after the date of the submission of an application, on an application that has been submitted and accepted for review under this subsection, or on a supplement to such an application, that is for a drug that— (i) has been introduced into interstate commerce by not more than one manufacturer or sponsor, as applicable, in the last 3 months and with respect to which tentative approval under paragraph (5) has been granted for not more than 2 applications