VAMA Board

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 other words, it is...

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 policy, pricing, and...

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 by the 505(b)(2)...