Zdrowie i gospodarka · 24/10/2022
FDA Releases Draft Guidance for Industry on In Vitro Release Test Studies for Topical Products
The FDA has made available a draft guidance document that provides recommendations for in vitro release test studies for topical products submitted in Abbreviated New Drug Applications (ANDAs), aiming to help applicants demonstrate bioequivalence between two topical products
Source: Federal Register — Food and Drug AdministrationOpen original release →