A bill to 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.
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.
Referred to the Subcommittee on Health.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line