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

 
• By Joanne S. Eglovitch

Despite in-vitro advances, FDA officials say more work is needed in refining alternative models before agency disbands its weight-of-evidence approach.

Woman Using Nose Spray

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...

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