FDA Releases Guidance on Utilizing Real-World Evidence for Pharmaceutical Regulatory Review Process

The FDA has published final draft guidance for pharmaceutical companies, indicating how they can use real-world evidence to support their applications during the regulatory review process for new treatments. The release aligns with the 21st Century Cures Act, which aims to expedite the development and patient accessibility of medical products. Since the inception of the Act, the use of real-world evidence and data for drug approvals has increased. However, the guidance emphasizes the necessity of drug manufacturers engaging with the agency during the early stages of drug development if they plan to use non-interventional research to back a marketing application. The FDA also encourages entering into contracts with all external data sources to ensure they can supply patient-level data for review.

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[Source: Pharmaceutical Technology, August 31st, 2023]