Revised Guidance for Industry and Reviewers on Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act

概要

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry and reviewers entitled ``Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act.'' The guidance clarifies the processes that will be followed in implementing this section of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). This revision includes clarification of the procedures applicable to bulk drug substances for products previously regulated under the Federal Food, Drug, and Cosmetic Act (the act).