New GDUFA Rules: What Does It Take to Be Successful?


  • April 24, 2019

Keys to Success Under GDUFA II

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.

1. Take Full Advantage of Meetings

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 new 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.

  1. The product development meeting provides for a discussion of specific scientific issues or questions in which the FDA will provide targeted advice regarding the ongoing ANDA development program.
  2. The pre-submission meeting provides an opportunity for prospective ANDA applicants to discuss and explain the format and content of the ANDA to be submitted.
  3. The mid-review-cycle meeting which is held only during the first review cycle with ANDA applicants that have participated in a prior product development or pre-submission meeting. This meeting affords an opportunity for the FDA to discuss issues identified during the review with the applicant.

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.

2.  Learn as Much as You Can

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.

3.  Learn from Your Mistakes

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.

4.  Pay Close Attention to Details

Learning as much as you can and learning from your mistakes 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.

5.  Be Sure Your Supply Chain is in Compliance

If you’ve sourced an active pharmaceutical ingredient (API) from a vendor, make sure that the vendor has fulfilled their GDUFA II requirements. They must file a drug master file at least six months in advance of when you plan to submit your ANDA because it must go through a separate review process 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.

6. Focus on Getting the Application Approved, Not Just Filed

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.

The Weinberg Group Knows What Success Looks Like

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.

To learn more about our services and how The Weinberg Group can help you achieve successful interactions with the FDA, contact us today.