Focusing on high-level strategies, this webinar will discuss ways to maximize 505(b)(2) benefits through case studies and the four pillars of drug development:
• How do I utilize a target product profile to position my product for the optimal market?
• What current prescribing habits and medical standard-of-care should be considered?
• How can I enhance existing science to achieve product differentiation?
• What are the regulatory opportunities? Which clinical studies are / are not necessary for 505(b)(2)?