How can the US Food and Drug Administration promote development of drugs in the central nervous system space? Katrin Rupalla, senior VP, head of regulatory affairs, medical documentation and R&D quality at Lundbeck Inc., believes the agency should apply an approach similar to that used in oncology for products being developed for dementia and cognitive impairment.
Rupalla spoke at a meeting FDA convened for stakeholders to provide review staff in the Center for Drug Evaluation and Research's Office of New Drugs (OND) with policy suggestions to...
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