FDA 'Consistency' Is Industry Watchword For Promoting Effective Drug Development
Pharma companies and associations cite numerous examples of getting inconsistent advice across review divisions, including the number of clinical trials required for rare disease drugs and acceptance of innovative clinical trial designs and novel endpoints.
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PhRMA, BIO and Pfizer call for predictable process for setting postmarket commitments and requirements, periodic reevaluation of their necessity and feasibility, and FDA acceptance of novel trial designs.
BIO and PhRMA ask agency to provide more guidance on trial implementation, data integrity and novel data sources.
Hylton Joffe was named acting director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine but also will continue to serve as Office of New Drugs acting deputy director; agency veterans Ellis Unger and Julie Beitz also tapped for clinical office leadership roles in final stage of massive reorg.