Sec. 806. Inspections
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/bill/115/hr/2430/eh/section-806·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Within 6 months of the date of enactment of this Act, the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ). Such protocol shall— apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 )— for which the approval is dependent upon remediation of conditions identified in the report; for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and where the drug that is the subject of the application is a drug— for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or that is included on the list under section 506E of such Act ( 21 U.S.C. 356e ); address expedited re-inspection of facilities, as appropriate; and establish a 6-month timeline for completion of review of such responses to such reports.
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