Exploring New Potential Through 505(b)(2)
When filing for a drug product approval via the 505(b)(2) regulatory pathway rather than a traditional development pathway, companies are afforded several advantages. The pathway — which was established, along with the 505(j), by the 1984 Hatch-Waxman Amendments of the Federal FD&C Act (the addition of the Drug Price Competition and Patent Term Restoration sections) — offers companies a streamlined route for drug approval.
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