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
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
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
