Adaptive pathways are an innovative and proactive approach to drug development and market access designed to maximize the positive impact of new drugs on public health. This approach seeks to strike a balance between providing timely access to promising medications for patients with urgent medical needs and ensuring the collection of evolving information on the benefits and risks of these drugs.
Under the adaptive pathway approach, a medicinal product may receive initial authorization for use in a limited or specific patient population. During this controlled use phase, additional clinical evidence is gathered through carefully designed studies or real-world data collection initiatives. The evolving data is continuously assessed to evaluate the product’s performance, safety, and efficacy in real-life settings.
Based on the evaluation of the collected data, the authorization of the drug may progress to a larger patient population or a broader indication. This iterative and adaptive process allows for the continuous assessment of the drug’s benefits and risks, enabling regulatory authorities to make well-informed decisions and ensure patient safety while still providing expedited access to those in need.
Signal Management Process
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