S 1463
Modernizing Therapeutic Equivalence Rating Determination Act
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Bill overview
This bill changes how the Food and Drug Administration (FDA) determines if a new drug is therapeutically equivalent to an existing one. Currently, companies seeking approval through a specific process (505(b)(2)) have to request a therapeutic equivalence rating separately. This legislation requires the FDA to provide this rating at the time of drug approval, or within 30 days, if the company requests it in their initial application. It also ensures the FDA considers related drugs and pending petitions when making these determinations.
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