On the recordMay 19, 2014
I think it is important to state that the intention of the limited population pathway is to still operate within the confines of safety and efficacy, and that is not altered.
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congress.govI think it is important to state that the intention of the limited population pathway is to still operate within the confines of safety and efficacy, and that is not altered.
Waxman emphasizes the importance of safety and efficacy in the new drug approval pathway.
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