Bill > S2910

This bill amends the Federal Food, Drug, and Cosmetic Act to change the 180-day exclusivity period for generic drug applications. The key provisions allow the Food and Drug Administration (FDA) to approve a generic drug application even if a first applicant is eligible for the 180-day exclusivity period, as long as certain conditions are met, such as at least 30 months have passed since the first applicant's submission and the first applicant's application is not yet effectively approved. The amendments apply only to generic drug applications filed after the enactment of this bill that do not include a certain type of certification that was made before the enactment.