Zdrowie i gospodarka · 13/07/2000

FDA Issues Interim Rule to Update ANDA Approval and Exclusivity Regulations

The FDA is issuing an interim rule to update its regulations regarding the timing of ANDA approvals and 180-day exclusivity, following recent court decisions that have led to the elimination of the current definition of court decisions.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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