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ec52 replied to the topic Product PMOA Classification with FDA Branches in the forum Introduction to Project Management 6 years, 2 months ago
Using a similar but different example, birth control implants are also combination products. The implant is a tiny, thin rod about the size of a matchstick. A doctor inserts the implant under the skin of the user’s upper arm. It releases the hormone progestin to stop the user from getting pregnant. In this case the implant is made of ethylene vinylacetate copolymer and serves as a reservoir for controlled release of progestin. The PMOA is attributed to the drug so review would be done primarily by CDER.