federal_register: 2013-21892

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-21892 Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate; salmeterol xinafoate. 2013-09-10 2013 9 https://www.federalregister.gov/documents/2013/09/10/2013-21892/draft-guidance-for-industry-on-bioequivalence-recommendations-for-fluticasone-propionate-salmeterol https://www.govinfo.gov/content/pkg/FR-2013-09-10/pdf/2013-21892.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate." The recommendations provide specific guidance on the...

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