Pharmaceutical Executive December 9, 2021
Critics proclaim that recent RWD guidance issued by FDA still has a good number of gaps to fill and may take some time to accomplish.
In September, FDA published guidance on strategies for accessing real-world data (RWD) from electronic health records (EHRs) and medical claims in support of submissions for drug and biologic approval. As Pharm Exec’s Jill Wechsler wrote (Oct. 1), “the diversity and limitations of this information has stymied broader adoption for documenting drug effectiveness.” In asking drug developers “to weigh in on strategies utilizing RWD to support regulatory decisions and to help define treatment exposure, outcomes, data quality assurance, and data quality control procedures,” FDA’s move looks toward satisfying the demand for faster development of medical products.
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