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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 .... Read More

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 .... Read More

Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures June 26, 2019

The FDA stands for Food and Drug Administration. FDA is a crucial part of the US Department that is dedicated towards offering health and human services. The primary function of this organization is to oversee the production of foods, pharmaceuticals, medical devices, and other consumer products.  The development of biological commodities that are used for … Continue reading Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures .... Read More

A Guide to ANDA Submissions Issued By The FDA June 5, 2019

ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, … Continue reading A Guide to ANDA Submissions Issued By The FDA .... Read More

What You Need To Know About The FDA GDUFA Self Identification Requirements April 30, 2019

Who is required to self-identify?As per the federal law, FDA self-identification is going to start from May 1st, 2019 and the facilities are required to submit their files as soon as possible. Each and every Drug company is requested to update, re-confirm and submit the self-identification form before June 1st, 2019. The manufacturer or any company who plans to become a manufacturer of human generic drug APIs or FDFs are required to self-identify. Any organization or company that package the FDF of human generic drugs into the primary container/closure system will also have to go through this process..... Read More

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