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Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective
Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective | US FDA has continued to evolve the regulatory space for combination products in the United States, EU MDR implementation is upcoming. Efforts to align definitions are underway through ASTM International. In this session we will get health authorities perspectives on the dynamic combination products regulatory space, what's working, what's challenging, what's next.
Speaker(s):
CAPT. Melissa
B. Burns,
Senior Program Manager, Office of Combination Products,
FDA/CDER