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Month: August 2019

FY 2020 GDUFA Fee Structure

FDA has now published FY 2020 GDUFA Fee.  Below is the summary of  FY 2020 GDUFA Fee structure. FY 2020 GDUFA FEE , ANDA Fee ANDA fee –  $ 176,237 DMF Fee – $57,795 Program Fee...

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FY 2020 Medical Device Registration Fee

FDA has published Medical Device Registration Fee for FY 2020 .FDA Medical device registration fee Medical Device establishment registration fee for FY 2020 is $5,236 , no waiver...

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