The FDA just un­veiled its new, prici­er fee sched­ule to re­view new drugs

With the new user fee deals signed in­to law, the FDA un­veiled a new in­creased fee sched­ule that will ap­ply to bio­phar­ma­ceu­ti­cal com­pa­nies for their pre­scrip­tion drug and biosim­i­lar ap­pli­ca­tions and pro­grams.

For pre­scrip­tion drugs re­quir­ing clin­i­cal da­ta, the price for FY 2018 will be about $2.4 mil­lion, which is near­ly $400,000 more than in 2017. For pre­scrip­tion drugs not re­quir­ing clin­i­cal da­ta, the fee will be about $1.2 mil­lion, which is about $192,000 more than 2017.

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