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.
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."