Generic Drug User Fee Amendments (GDUFA) has bought a lot of changes when it comes to the processing aspects of the generic drugs. Read this article to get insights on what has changed over the course of time and what are the things that have remained tact.
GDUFA, which is an acronym for Generic Drug User Fee Amendments was initiated in 2012 by Congress. The primary aim behind this was to speed up the process to provide safe and effective drugs to the public and also reduce the manufacturing costs in the industry. In addition to several important changes, it also authorized the FDA to gather user fees from the manufacturing companies to reduce the cost of reviewing generic drugs and policing in the industry. Under this act, GDUFA requires the manufacturing units who are engaged in generic drug activities to provide a self-authentication on an annual basis where they need to pay the user fee that is set for the agency itself.
In 2016, GDUFA was revised by the FDA under which certain changes were made with respect to the processing of the generic drugs. Again the fee schedule of FDA was updated in the year 2018. Initially, under GDUFA, the generic drug manufacturers were required to pay a certain amount if they were listed under New Drug Application (ANDA) even when they were under a review or were already approved. In the latest versions, only those applicants who have been approved by the ANDA are required to pay the fee. In addition, there is a provision made for the manufacturers who are working on a contractual basis who need to pay a reduced fee than those who hold their ANDAs.
In September 2016, FDA released final guidance for the GDUFA self-identification submission. Under this, the members who have submitted their documents related to self- identification in the past they need to follow these major aspects:
• They need to submit the documents Structured Product Labeling (SPL) format
• DUNS Numbers along with FDA-issued Facility Establishment Identifiers (FEI) are required to be listed during the submission process.
Not only this, one of the most important aspects of this guideline is that the reporting period is not changed and the submission needs to be made annually between May 1 and June 1. The date of submission is issued by the Federal Government every year, which usually lies between October 1 to September 30 and submissions need to be completed in May.
As the companies need to remain prepared for the submission, it is necessary to start early on with the entire process so that you do not have to hurry at the last moment for getting the documents ready for the application process.
Each year certain changes are made in the amendment which is why it is necessary for you to remain updated on them.
FDA basics provide help with generic drug reviewing aspects such as DMF filings, ANDA/NDA filings, and Establishment Registration. Check out their website to know about their services.