RAPS Reports Reduction in Certain GDUFA User Fees for 2017

The revised user fees will go into effect October 1, 2016 and remain in effect through the end of September 2017.  It is important to note that not all fees will be reduced, and some will increase.  Following is an excerpt of the story, recently published in Regulatory Focus describing key changes:

ANDA ($70,480, down from $76,030 in 2016), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in 2016), domestic active pharmaceutical ingredient (API) facility ($44,234, up from $40,867 in 2016), foreign API facility ($59,234, up from $55,867 in 2016), domestic finished dose formulation (FDF) facility ($258,646, up from $243,905), and foreign FDF facility ($273,646, up from $258,905 in 2016).

Click here for the full story or here for help with your drug or medical device submission.