federal_register: 99-16140

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-16140 Draft Guidance for Industry on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.'' This draft guidance document provides recommendations to applicants intending to provide studies to document bioavailability (BA) or bioequivalence (BE) in support of new drug applications (NDA's), or abbreviated new drug applications (ANDA's) for locally acting nasal aerosols (metered-dose inhalers) and nasal sprays (metered-dose spray pumps). 1999-06-24 1999 6 https://www.federalregister.gov/documents/1999/06/24/99-16140/draft-guidance-for-industry-on-bioavailability-and-bioequivalence-studies-for-nasal-aerosols-and https://www.govinfo.gov/content/pkg/FR-1999-06-24/pdf/99-16140.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.'' This draft guidance document provides...

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