Sec. 102. Enhance intra-agency coordination and public health assessment with regard to compliance activities
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Section 506D of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356d ) is amended by adding at the end the following: The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding the reviews of reports shared pursuant to section 704(b)(2), and any feedback or corrective or preventive actions in response to such reports. .
Section 506C–1(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1(a)(2) ) is amended to read as follows: describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication; provides the number of reports described in section 704(b)(2) that were required to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortage and the number of such reports that were sent; and describes the adoption and utilization of the approach described in section 506D(g); .
(a)The amendment made by subsection
(a)shall apply beginning on the date of enactment of this Act.
(b)The amendment made by subsection
(b)shall apply beginning on the date that is 1 year after the date of enactment of this Act.
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- 21 USC 356c–1(a)(2)
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Sec. 102
Enhance intra-agency coordination and public health assessment with regard to compliance activities
Cite21 USC 356c–1(a)(2)
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