FDAnews
www.fdanews.com/articles/152550-fda-combo-product-postapproval-guidance-urges-manufacturers-to-anticipate-changes

FDA Combo Product Postapproval Guidance Urges Manufacturers to Anticipate Changes

January 21, 2013
Makers of drug-device combination products are urged to anticipate postapproval changes they may wish to make, and develop protocols for preparing modification proposals, according to new FDA draft guidance. Manufacturers should establish protocols for demonstrating comparability of any modifications to approved products involving manufacturing methodology or product components.
Drug Industry Daily