Sec. 308. Guidance regarding development and submission of chemistry, manufacturing, and controls information for expedited approval
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The Secretary of Health and Human Services shall— not later than 6 months after the date of the enactment of this Act, issue draft revised guidance to provide clarity regarding the development and submission of chemistry, manufacturing, and controls information for purposes of subsections (a), (b), (c), and
(g)of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ; relating to breakthrough therapies, fast track products, accelerated approval, and regenerative advanced therapies); and not later than 90 days after the close of a period of public comment on such draft guidance, finalize the guidance. The guidance under subsection
(a)shall address— how the Food and Drug Administration will determine how, and by when, chemistry, manufacturing, and controls information is required to be submitted throughout development and during the pre- and post-approval phases, taking into consideration— how such determinations will reflect the risks and benefits of such information given the seriousness or life-threatening nature of the disease the product is intended to diagnose, cure, mitigate, treat, or prevent; the phase and expedited nature of development; and the availability of relevant data and information from nonclinical and clinical studies, product applications, and post-approval oversight; and how the Food and Drug Administration will provide ongoing advice and opportunities for sponsors to interact with the Food and Drug Administration on, and how the Food and Drug Administration will facilitate, the submission of chemistry, manufacturing, and controls information throughout the life cycle of the product.
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Sec. 308
Guidance regarding development and submission of chemistry, manufacturing, and controls information for expedited approval
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