-
mjf34 replied to the topic Primary Mode of Action (PMOA) in the forum Introduction to Advanced Medical Device Development 8 years, 2 months ago
Hello Fady,
I have a small amount of experience in working with PMOA’s for combination products. In my experience, I have worked with drug/device PMOA’s and the separation of two drugs until consumer use (for example: two active vitamins are separated until the granulate is poured from the package, which contains 2, independent chambers.)
In most cases, we found that it was fairly straightforward to determine the PMOA but in the instance that we did not, we would meet with and discuss with the regulatory affairs department to determine what PMOA was most suitable for the product.-Michelle