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Our recent participation in the European Repurposing 4 EU conference in Barcelona highlighted significant challenges and opportunities in the development and commercialization of repurposed drugs, particularly within the EU and U.S. markets. This post explores how advanced technologies—especially those leveraging artificial intelligence (AI)—can transform the value proposition for repurposed drugs, with a focus on regulatory, reimbursement, and distribution strategies enabled

Welcome to our new website and a whole new world where expertise in value added medicines is just a click or request away. The 505(b)(2)...

Are you involved in the development and marketing of value-added medicines like 505(b)(2)s? If so, you may find the latest insights on...

Value-added medicines play a crucial role in the healthcare industry, offering innovative solutions to meet patients' needs. Recently,...

Implementing Congress’s Incentive to Use §505(b)(2)’s to Measure Clinical Benefit in Real World Settings 1. Background Congress enacted...

505(b)(2)s and Women’s Health Issues By using the 505(b)(2) new drug application pathway, sponsors can add value to already approved...