The Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) will host a free public workshop on Nov. 3, 2022: Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development.
The purpose of this workshop is to discuss efficient, science-based bioequivalence (BE) approaches in development that may be useful for certain prospective generic products that are compositionally different compared to the reference standard. These approaches may utilize sophisticated techniques that have been developed to characterize the physical, structural, sensorial and thermodynamic properties of topical drug products applied on the skin, as well as in vivo cutaneous pharmacokinetics (PK) studies. The workshop will provide an update on the progress of research activities funded by the Generic Drug User Fee Amendments, explore challenging issues that would benefit from broader discussion, identify areas that should be targeted with further research, and discuss opportunities for coordination and collaboration between FDA, the generic industry, academic institutions, contract research organizations, consultants and others involved in generic drug development.
This workshop is FREE. Register now.