Zdrowie i gospodarka · 24/06/1999

FDA Releases Draft Guidance for Nasal Aerosol and Spray Studies

The Food and Drug Administration (FDA) has released a draft guidance document titled "Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action," which provides recommendations for pharmaceutical companies seeking to support new drug applications for locally acting nasal products. The guidance aims to standardize the requirements for bioavailability and bioequivalence studies for nasal aerosols and sprays.