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Home » Responding to Real-World Data Guidance, Industry Calls for Flexibility and Further Clarity
Responding to Real-World Data Guidance, Industry Calls for Flexibility and Further Clarity
Prominent industry figures have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in trials, but they hope it will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors adjust to the new recommendations.