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Guidance Issuing OfficeCenter for Drug Evaluation and Research
Section 125 of Title I of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), signed into law by President Clinton on November 21, 1997, repealed section 507 of the Federal Food, Drug, and Cosmetic Act (the Act). As a result of the repeal of section 507, which took effect immediately, several of the Agency's administrative processes for reviewing and approving antibiotic drug applications must be changed. This document is intended to clarify, on an interim basis, the administrative processes that will be followed in implementing section 125 of the Modernization Act. In the current revision, the Agency clarifies the procedures applicable to bulk drug substances for products previously regulated under section 507.
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Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-1998-D-0864.