Sec. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS
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## SEC. 807 REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS Not later than 180 calendar days after the date of enactment of this Act, and quarterly thereafter until October 1, 2027, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration a report that provides, with respect to the months covered by the report— ####
(1)with respect to applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that, during the most recent calendar year, were subject to priority review under paragraph
(11)of such section 505(j) (as added by section 801) or expedited development and review under section 506H of the Federal Food, Drug, and Cosmetic Act (as added by section 803), the numbers of such applications (with denotation of such applications that were filed prior to October 1, 2014) that are— #####
(A)awaiting action by the applicant; #####
(B)awaiting action by the Secretary; and #####
(C)approved by the Secretary; ####
(2)the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and prior approval supplements withdrawn in each month; ####
(3)the mean and median approval and tentative approval times and the number of review cycles for such applications; ####
(4)the number and type of meetings requested and held under such section 506H (as added by section 803); and ####
(5)the number of such applications on which the Secretary has taken action pursuant to subsection
(c)of such section 506H (as added by section 803) and any effect such section 506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles for such approvals.
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Sec. 807
REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS
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