Sec. 801. PRIORITY REVIEW OF GENERIC DRUGS
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## SEC. 801 PRIORITY REVIEW OF GENERIC DRUGS 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)> > Subject to subparagraph (B), the Secretary shall prioritize the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection that is for a drug— > > > ###### “(i) > > for which there are not more than 3 approved drug products listed under paragraph
(7)and for which there are no blocking patents and exclusivities; or > > > ###### “(ii) > > that has been included on the list under section 506E. > > > ##### “(B) > > To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph
(A)or that the Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection. > > > ##### “(C) > > The Secretary may expedite an inspection or reinspection under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A). > > > ##### “(D) > > Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate. > > > #### “(12) > > The Secretary shall publish on the internet website of the Food and Drug Administration, and update at least once every 6 months, a list of all drugs approved under subsection
(c)for which all patents and periods of exclusivity under this Act have expired and for which no application has been approved under this subsection.” > .
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Sec. 801
PRIORITY REVIEW OF GENERIC DRUGS
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