AdvaMed submitted comments to the FDA regarding the draft guidance on the "least burdensome" concept, asking the agency to provide more clarification on the application of the concept's principles. "Missing from this brief treatment of a 'key principle' is an example -- drawn from FDA practice or an applicable fact pattern -- of balancing pre- and postmarket information needs to reach a least burdensome result," AdvaMed said.
AdvaMed comments on FDA's "least burdensome" guidance
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