FDA Releases Draft Guidance on Listed Drugs, 30-Month Stays, and Approval of ANDAs and NDAs Under Hatch-Waxman Act

Summary

The FDA is releasing a draft guidance document to clarify the definition of 'listed drugs' for pharmaceutical companies, following the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The guidance aims to provide clarity on when changes to drug applications require a new application, and how to handle 30-month stays and approval of abbreviated new drug applications (ANDAs) and new drug applications (NDAs).