FDA To Join The 'Real World' Under PDUFA VI
Regulators pledge to explore the use of real-world evidence, strengthen the patient's voice in drug review, and boost the agency's postmarketing surveillance abilities as part of sixth round of user fee program with industry.
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Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.
In a journal article, Center for Drug Evaluation and Research Director Janet Woodcock and colleagues describe the sources of real-word evidence and study designs that can be used to generate such evidence.
US agency has started transitioning to a new model for Patient-Focused Drug Development meetings, with agency officials attending four externally hosted meetings so far, with at least three more planned for the next few months. So far, the Neurology Products Division has been particularly active with the external meetings.