Patient-Focused Drug Development High On Industry’s List Of PDUFA VI Tweaks
BIO and PhRMA want patient input gathered through a more structured and data-driven process than the current disease area meetings under PDUFA V, which are “anecdotal” in nature; National Organization for Rare Disorders seeks an interactive portal between patient community and FDA reviewers.
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FDA floats idea of central office to coordinate patient engagement for symbolic as well as practical reasons.
Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.