federal_register: 2015-17726

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2015-17726 Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled "Bioequivalence Recommendations for Lubiprostone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules. 2015-07-20 2015 7 https://www.federalregister.gov/documents/2015/07/20/2015-17726/bioequivalence-recommendations-for-lubiprostone-revised-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2015-07-20/pdf/2015-17726.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled "Bioequivalence Recommendations for Lubiprostone." The recommendations provide specific guidance on the...  

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