Learning Tracks

Post-approval changes are subject to various regulatory requirements and discussed in guidance. SUPAC guidances provide specific examples of reporting categories for the classes of drugs they cover (e.g., SUPAC- IR, SUPAC-MR, SUPAC-SS). Some classes of drugs are not covered by the SUPACs (e.g., transdermal products). Complex generics, including drug-device combination products, are currently not addressed in guidance. This session will include discussion of ideas for facilitating management and assessment of post-approval changes, including the pros and cons of using the lifecycle management approach in ICH Q12.