Issue Date: April 3, 2003
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics, Generic Drugs
Status: Draft
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.”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 The draft guidance was originally issued for comment on June 24, 1999. Since many substantive changes have been made to the guidance, it is being reissued for comment as a level 1 draft guidance.
Download the Guidance Document
