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For example, under Hatch-Waxman, the application that begins the FDA approval process for the generic firm is called an Abbreviated New Drug Application (ANDA).
Brand name drug manufacturers have an understandable incentive to delay approval of the ANDA.
One lawful mechanism that brand name companies can use that may have the effect of delaying the approval of an ANDA is the filing of a Citizen Petition with the FDA.
The trial exhibits (below) were part of a PowerPoint presentation that explained how differently Citizen Petitions and ANDAs are handled at the FDA.
Similarly, in the "Hatch Waxman ANDA Bioequivalency Exhibit" (below), the straightforward area graphs show a jury how the proposed generic drug has a different concentration level and is thus not bioequivalent.
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