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A Crucial Regulatory Moment As we approach June 2026, a pivotal opportunity has emerged for the Value-Added Medicines Alliance. The FDA has officially released a request for comment regarding the repurposing of existing drugs, a core pillar of our mission to enhance patient outcomes through innovation. This request is not merely a formality; it is a call for specialized expertise. Your clinical insights and industry perspective are essential in helping the FDA understand the

Headlines about the Trump Administration’s proposal to move marijuana to Schedule III have generated a lot of excitement. That excitement should be tempered with a realistic timeline, and a clear-eyed plan for what it would actually take to succeed. The opportunity is real, but it will favor teams that pair strategy with economics, regulatory discipline, and patience. The Federal Register publication is a notice of proposed rulemaking under the Controlled Substances Act. In o

Meeting synopsis | March 24, 2026 | New York City The Value Added Medicines Alliance (VAMA) convened senior leaders from across the 505(b)(2) and value-added medicines ecosystem in New York City for its highly successful 6th Annual Meeting, Adapting for Change. In keeping with the high bar set in prior years, the 2026 program again featured an exceptional faculty experienced regulators, strategists, and innovators, focused on the practical decisions companies must make as pol

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...