Module 18 2021

07/02/2021

Primary Mode of Action (PMOA)

Defined in 21 CFR Part 3

“the single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action that is expected to make the greatest contribution to the overall intended therapeutic effects of the combination product”

The Organisation for Professionals in Regulatory Affairs

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Lead center review

• The Lead Center is the FDA centre that has been assigned the review responsibility.

• May be reviewed in consultation with another centre

• May also be reviewed in collaboration with another centre.

The Organisation for Professionals in Regulatory Affairs

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