federal_register: 2014-29035

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2014-29035 Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Budesonide Extended-Release Tablets." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets. 2014-12-11 2014 12 https://www.federalregister.gov/documents/2014/12/11/2014-29035/bioequivalence-recommendations-for-budesonide-extended-release-tablets-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2014-12-11/pdf/2014-29035.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Budesonide Extended-Release Tablets." The guidance provides specific recommendations on the design of...

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