'Prac­ti­cal­ly clean' FDA user fees reauth will be in­clud­ed in spend­ing bill wrap­ping up next week

The long and wind­ing road to reau­tho­riz­ing FDA’s quin­quen­ni­al user fees for pre­scrip­tion drugs, gener­ics, biosim­i­lars and med­ical de­vices fi­nal­ly has a light at the end of it.

While ne­go­ti­a­tions are still on­go­ing on which pol­i­cy rid­ers (ac­cel­er­at­ed ap­proval re­forms, et. al.) may be in­clud­ed, a se­nior GOP com­mit­tee aide con­firmed to End­points News Thurs­day that at the very least, an agree­ment has been reached for the FDA user fee deals, which are good through 2027, to be in­clud­ed in the con­tin­u­ing res­o­lu­tion.

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