FDA-CRCG Workshop on In Vitro Release Test (IVRT) and In Vitro/In Vivo Correlation (IVIVC) of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products
Virtual Workshop
The purpose of this workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking for IVRT and IVIVC studies to support the development and approval of complex generic ophthalmic, injectable, implantable, and inserted products.
FDA-CRCG Workshop on Using Model Integrated Bioequivalence (BE) Approaches in Complex Generic Product Development
Virtual Workshop
The purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro data and other knowledge to support the development of complex generics that may otherwise rely upon challenging in vivo studies to demonstrate bioequivalence.
FDA-CRCG Workshop on Evaluation of Cutaneous Pharmacokinetics to Facilitate Complex Generic Topical Product Development
Virtual Workshop
The purpose of this workshop is to discuss recent advances in in vivo methodologies that have the potential to demonstrate the bioequivalence of topical dermatological products in a manner that is more efficient than comparative clinical endpoint bioequivalence studies.
FDA-CRCG Training on Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned
Virtual Training
The purpose of this workshop is to clarify FDA’s regulatory expectations and practices for conducting formulation assessments with generic products under development across different routes of administration, and to discuss best practices and lessons learned with the goal of minimizing the potential for formulation-related issues that can otherwise adversely impact a regulatory decision on the filing or approval of an abbreviated new drug application.
