federal_register: 2012-23177

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2012-23177 Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Pentosan Polysulfate Sodium." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for pentosan polysulfate sodium capsule. 2012-09-20 2012 9 https://www.federalregister.gov/documents/2012/09/20/2012-23177/draft-guidance-for-industry-on-bioequivalence-recommendations-for-pentosan-polysulfate-sodium https://www.govinfo.gov/content/pkg/FR-2012-09-20/pdf/2012-23177.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Pentosan Polysulfate Sodium." The recommendations provide specific guidance on the design of...

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