Complex Generics: US FDA Still Wants Comparative Clinical Endpoint Studies For Inhaled, Nasal Drugs

Despite promising research on in-vitro approaches to demonstrating bioequivalence of complex orally inhaled and nasal generic drug products, US FDA officials say they still expect generics firms to show bioequivalence with a weight-of-evidence approach that includes comparative clinical endpoint studies.

They made this point at a Jan. 9 public workshop, “New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products.” The purpose of the workshop was to present the outcomes of research projects funded under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research Program