The Center for Drug Evaluation and Research (CDER) has compiled a comprehensive dataset detailing all New Molecular Entities (NMEs) and new biological products approved between 1985 and 2019. This compilation includes both small molecule drugs sanctioned under New Drug Applications (NDAs) and novel biologics, providing a crucial resource for industry stakeholders.
This extensive listing not only highlights the regulatory milestones achieved over three decades but also reflects the evolving landscape of pharmaceutical innovation. The data underscores the increasing complexity and diversity of therapeutic options that have emerged, driven by advancements in science and technology.
For professionals in regulatory affairs, quality assurance, and sourcing, this dataset serves as a vital reference point for understanding historical approval trends and the regulatory environment. It can inform strategic decisions in drug development and portfolio management, ultimately aiding in the navigation of future approvals and market dynamics.
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