A bill to amend the Federal Food, Drug, and Cosmetic Act, as amended, to require the submission of certain additional information by applicants for new drugs; to require the inclusion of certain additional information in drug labeling; and for other purposes.

Amends the Federal Food, Drug, and Cosmetic Act to require a statement of: (1) biological criteria relating to therapeutic effectiveness and safety; and (2) performance data relating to such biological criteria, as part of the application for approval of a new drug under such Act.

Requires that such information also be on the labeling of a new drug approved for marketing.