Services to Ease FDA Regulatory Compliance

Monthly Archives: August 2019

NDC code requirement and application process explained August 21, 2019

How can I apply for NDC code ? NDC stands for National Drug Code which is also used for billing and  insurance purpose. NDC is 10 digit code . Each drug product should have unique NDC code.     First  five digits of NDC code are assigned by FDA, which is known as labeler code. … Continue reading NDC code requirement and application process explained

FY 2020 GDUFA Fee Structure August 19, 2019

FDA has now published FY 2020 GDUFA Fee.  Below is the summary of  FY 2020 GDUFA Fee structure. ANDA fee –  $ 176,237 DMF Fee– $57,795 Program Fee for ANDA applicants     Large Size $ 1,590,792 $ 1,862,167 $ 1,661,684 Medium Size $ 636,317 $ 744,867 $ 664,674 Small Size $ 159,079 $ 186,217 $ … Continue reading FY 2020 GDUFA Fee Structure

FY 2020 Medical Device Registration Fee August 8, 2019

FDA has published  Medical Device Registration Fee for  FY 2020 . Medical Device establishment registration fee  for FY 2020 is    $5,236 , no waiver or fee reduction for small companies. Medical device registration fee FY 2020  will be effective from 1st October , 2019.  In order to renew  registration   for FY2020 , medical device … Continue reading FY 2020 Medical Device Registration Fee

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