A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a standard for determining substantial evidence of a drug's effectiveness for purposes of revocation of an approval of a new drug application under section 505 or repeal of a certification of antibiotics under section 507.

Establishes, under the Federal Food, Drug, and Cosmetic Act, a standard for determining substantial evidence of a drug's effectiveness for purposes of revocation of an approval of a new drug application under such Act, or repeal of a certification of antibiotics under such Act. (Amends 21 U.S.C. 355)