Combination product regulation: FDA clarifies "primary mode of action"
This article was originally published in Clinica
The FDA has made sure not to upset the status quo in its new proposed rule on how it will decide which of its agencies will take the lead in reviewing combination products. The proposed rule is "consistent with the way we've been doing things the last 13 years", Mark Kramer, director of the agency's office of combination products, told reporters yesterday.
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