FDA Issues Guidance on Bioequivalence
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
FDA has published Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate. The guidance recommends in-vitro and in-vivo studies to establish bioequivalence (BE) of the test (T) and reference (R) dry powder inhalers containing fluticasone propionate and salmeterol xinafoate.
The guidance recommends single actuation content, aerodynamic particle size distribution in-vitro, and the fasting pharmacokinetic (PK) BE studies for all strengths of the T and R products. Clinical endpoint study is recommended for the lowest strength of the T and R products.
Entering New Domains for 3D Printing of Drug Products
April 6th 20253D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
