S. 1315 would amend the Federal Food, Drug, and Cosmetic Act to define the term "first applicant" for purposes of filing an abbreviated application for a new drug.
Detailed Summary
Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
Status of the Legislation
Latest Major Action: 6/22/2009: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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