federal_register: 03-8010

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03-8010 Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action."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 document provides recommendations to applicants planning product quality studies to document bioavailability (BA) or bioequivalence (BE) in support of new drug applications (NDAs), or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers) and nasal sprays (metered-dose spray pumps). The draft guidance was originally issued for comment on June 24, 1999. Since many substantive changes have been made to the guidance, it is being reissued for comment as a level 1 draft guidance. 2003-04-03 2003 4 https://www.federalregister.gov/documents/2003/04/03/03-8010/draft-guidance-for-industry-bioavailability-and-bioequivalence-studies-for-nasal-aerosols-and-nasal https://www.govinfo.gov/content/pkg/FR-2003-04-03/pdf/03-8010.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action."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 document provides...

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