federal_register: 2015-10479

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-10479 Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System." This guidance provides recommendations for sponsors of investigational new drug applications (INDs), and applicants that submit new drug applications, abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of in vivo bioavailability (BA) and/or bioequivalence (BE) studies. 2015-05-06 2015 5 https://www.federalregister.gov/documents/2015/05/06/2015-10479/waiver-of-in-vivo-bioavailability-and-bioequivalence-studies-for-immediate-release-solid-oral-dosage https://www.govinfo.gov/content/pkg/FR-2015-05-06/pdf/2015-10479.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics...  

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