Sec. 104. Enhancing transparency of drug facility inspection timelines
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Section 902 of the FDA Reauthorization Act of 2017 ( 21 U.S.C. 355 note) is amended to read as follows: Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the public website of the Food and Drug Administration information related to inspections of facilities, including inspections that are necessary for approval of a drug under subsection
(c)or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), approval of a device under section 515 of such Act ( 21 U.S.C. 360e ), or clearance of a device under section 510(k) of such Act ( 21 U.S.C. 360(k) ) that were conducted during the previous calendar year. Such information shall include the following: The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including— the median time for drugs described in section 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(11)(A)(i) ); the median time for drugs described in section 506C(a) of such Act ( 21 U.S.C. 356c(a) ) only; and the median time for drugs on the drug shortage list in effect under section 506E of such Act ( 21 U.S.C. 356f ). The median time from the issuance of a report pursuant to section 704(b) of such Act ( 21 U.S.C. 374(b) ) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs
(A)through
(C)of paragraph (1). The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the actions indicated to address the conditions or practices observed during an inspection. The number of facilities that were unable to implement requested corrective or preventive actions following a report pursuant to such section 704(b), resulting in a withhold recommendation, including the number of such times for each category of drugs listed in subparagraphs
(A)through
(C)of paragraph (1). .
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Sec. 104
Enhancing transparency of drug facility inspection timelines
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