Regulatory Considerations for Developing Orphan Drugs
Developing orphan drugs involves navigating a complex regulatory landscape. Agencies like the FDA and EMA provide incentives such as expedited review processes, grants, and market exclusivity to stimulate orphan drug development. However, the limited size of clinical trial populations presents challenges for meeting rigorous safety and efficacy standards. Real-world evidence and adaptive clinical trial designs are increasingly important for supporting regulatory approval. Clear communication between stakeholders ensures patient safety while facilitating timely access to new therapies.
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