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ARTICLES & ADVISORIES

APR 5 2011

Food & Drug/Biomedical Update: Changes to Paragraph IV Patent Certification in the Medicare Prescription Drug, Improvement, and Modernization Act

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 includes several amendments to the Federal Food Drug and Cosmetic Act. One of those amendments eliminates the 30-month stay of approval of generic drugs when an Abbreviated New Drug Application is amended to include a paragraph IV certification for a patent that is listed with FDA after FDA accepts the Abbreviated New Drug Application.

Donald E. Segal contributed to this advisory.