505(b)2 – Innovations for US Market
Rajan Verma,
Associate Director and Head,
Perrigo Company plc
This talk will provide practical review on 505(B)(2) – Introduction and regulatory guidance, Examples of 505(B)(2) applications, Strategies for development of 505(B)(2) products, Challenges in development of 505(B)(2) products and Case studies.
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