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www.fdanews.com/articles/134391-fda-stern-with-generic-drug-makers-as-user-fee-negotiations-draw-near

FDA Stern With Generic-Drug Makers as User-Fee Negotiations Draw Near

February 17, 2011
The FDA is preparing to launch formal user-fee negotiations with generic-drug makers by the end of the month and agency officials are taking a hard line with industry in the build up. Saying there is a “significant fairness factor” in imposing the fees, Peter Beckerman, a senior policy advisor in the FDA Office of the Commissioner, told generic-drug makers Feb. 10 that their industry should not be exempt from a program that both brand drug and medical-device makers are already a part of.
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