505(b)(2) Drug Development Pathway

February 19, 2016White Paper

The 505(b)(2) is quickly becoming one of the most popular alternative pathways to drug development. Pharma companies are increasingly using this pathway to get new doses or formulations, including biosimilars, approved by the FDA. This pathway encourages innovation while decreasing time to market. In the following white paper, discover potential benefits of drug development via the 505(b)(2) pathway, as well as how to prepare for the application.

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