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Combination Products

03/20/06 AdvaMed responses to FDA request for comments to the draft concept paper on “Postmarket Safety Reporting for Combination Products” (pdf)
07/08/05 AdvaMed's submitted written comments and proposals concerning cross-labeling for combination technologies
Part 1 (pdf) Part 2 (pdf)
08/20/04 AdvaMed Comments Concerning Combination Products and 'Primary Mode of Action' Rule (pdf)
02/26/04 AdvaMed Comments to FDA on Office of Combination Products' Annual Report to Congress (pdf)
07/08/03 Testimony at FDA Workshop 'Innovative Systems delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges (pdf)