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alexandrabuga replied to the topic "FDA Regulations of Medical Device-Drug" – 5 years, 11 months ago
I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER. When looking at the additional OCP link @wms7 provided, I found that… Read more»
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alexandrabuga replied to the topic FDA Regulations of Medical Device-Drug in the forum Introduction to Project Management 7 years, 2 months ago
I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER.
When looking at the additional OCP link @wms7 provided, I found that if OCP doesn’t have enough information to determine the PMOA of a product directly or cannot determine the…[Read more]
