GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022. The continuing goal of the amendment is to facilitate timely access to high-quality, affordable generic drugs. Here are six things that Sponsors should do to significantly increase the chances of getting their ANDA submitted and approved under the new GDUFA rules.
Under GDUFA II, in addition to committing to review ANDAs within ten months of submission, the FDA developed a program to assist ANDA applicants with complex products before their application is submitted.
It’s highly recommended that applicants take full advantage of the pre-ANDA program. According to FDA guidance on the subject, this pre-ANDA program is intended to “clarify regulatory expectations for prospective applicants early in product development, assist applicants to develop more complete submissions, promote a more efficient and effective ANDA review process, and reduce the number of review cycles required to obtain ANDA approval.”
To facilitate the development of complex products, the FDA created a series of three meetings between prospective ANDA applicants and the Agency to discuss the proposed complex product and support the submission of a high-quality, approvable ANDA.
Ultimately, having access to these meetings can set Sponsors up to have a more successful submission and thus a more successful review cycle to get through the approval process as painlessly as possible.
Education is a crucial key to success. The Office of Generic Drugs is very strict when it comes to ANDAs, so it is essential that applicants learn as much as they can about the process and their responsibilities before beginning to prepare and submit an ANDA.
The FDA issues lots of guidance documents, and each applicable guidance should be reviewed, understood, and applied. Applicants should also attend relevant conferences and webinars to learn the do’s and don’ts throughout the generic drug development process and the submission of their ANDA.
If you have submitted an ANDA in the past and have received comments from the Office of Generic Drugs, pay close attention to them. Learn from any mistakes you made and be sure not to make the same mistake again.
Learning as much as you can and learning from prior FDA feedback is not enough. You must pay close attention to the details when compiling your submission. Again, the Office of Generic Drugs is strict when it comes to reviewing ANDAs, and things like typos that you might consider to be minor errors may trip up your application. If there are ten or more minor deficiencies, the Agency can issue a refusal to receive, and your application won’t make it through the door. You will have to start over and you will have lost a portion of your filing fee.
The FDA has issued a number of guidance documents on good ANDA submission practices. Take the time to read and understand them and then apply what you’ve learned.
If you’ve sourced an active pharmaceutical ingredient (API) from a vendor, make sure that the vendor has fulfilled their GDUFA II requirements. Submission of a drug master file (DMF) for the API is not required. However, if a DMF is to be filed, it is recommended that the DMF holder file the DMF at least six months in advance of when you plan to submit your ANDA because it must go through a separate review process (Completeness Assessment) to make sure that it is acceptable and considered available for reference. Because this process takes time, the earlier the vendor and the ingredient get vetted, the better.
Getting the ANDA filed is just the first hurdle; it is strategically important to focus on the end goal, which is getting the application approved. Applicants that focus on approval typically submit better and more complete applications. By thinking ahead, they eliminate the opportunities for negative comments during the review process.
Our highly experienced team of cross-trained experts have taken applicants like you where you are trying to go. Thanks to our frequent interaction with the FDA across a wide range of product categories, we know what success looks like. You can rely on us to assist you with anything from reviewing the content of your ANDA to preparing you for those all-important meetings and everything else in between. Set yourself up for success by contacting us early in the development process.
March 9, 2021
In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...
March 9, 2021
As a way to verify that your cleaning or cleaning-in-place (CIP) process was successful, what tool, assay or method should you use first? Well, shouldn’t the answer be as plain as the eyes on your...
March 9, 2021
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...