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NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS September 6, 2019

Have you received the email from FDA with  NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS  ?  Here is the  detailed action plan for you.   FDA has started sending emails  to labelers (manufacturer /brand owner of the product )   notifying  about the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS” .  There are … Continue reading NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS .... Read More

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 .... Read More

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

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