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FDA hosts public forum on reform for generics regulations, approvals
To ensure the intended balance between encouraging innovation in drug development and accelerating the availability of lower cost alternatives to innovator drugs, the FDA held a forum to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments.“In too many places people cannot afford the medicines that they need,” Scott Gottlieb, MD, FDA Commissioner, said during his opening remarks. “We have a system that supports market-based pricing for innovation as a way to provide proper incentives to entrepreneurs for taking on the uncertainty of these costly (Read more...)