federal_register: 2016-01683

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2016-01683 Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets. 2016-01-28 2016 1 https://www.federalregister.gov/documents/2016/01/28/2016-01683/bioequivalence-recommendations-for-lamotrigine-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-01-28/pdf/2016-01683.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' The recommendations provide specific guidance on the...  

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