Are You 100% Ready for FDA Submission?

March 7, 2016


In late 2014, the FDA announced that, starting December 17, 2016, all new clinical and nonclinical studies must be submitted electronically and contain data in conformance with the standards specified in FDA’s Data Catalog. This is part of an effort to accelerate the regulatory review process.

At the time of this writing, that deadline is only nine months away. So, the big question looms: Are you 100% ready for FDA submission? Because when December 17th comes, any doubt you have may represent a risk of slowing down the review process. More importantly, you’ll be missing out on an opportunity to get your new drug to market faster than ever before.

What's Changed, and Why?

Over the last several years, sponsors have submitted electronic study data to the FDA in greater volumes, and those submissions have grown in complexity. This has created a virtual “data dump” for FDA reviewers to contend with. This increasing mountain of collective data, which is largely unstructured and difficult to access, is time-consuming and exhausting for reviewers to navigate through.

Just a few years ago, when the FDA received a submission, reviewers spent up to 45 days just assessing the quality of that submission. Getting through this “pre-review,” plus the time spent by the submitting organization to fix these issues and resubmit, can waste valuable months. Reducing this time is highly beneficial to all stakeholders including FDA, pharmaceutical companies, and patients.

To that end, the development and rollout of a modern NDA and BLA review process was vital. The FDA JumpStart program was created to both accommodate electronic standardized submissions, and to provide the intelligent tools to quickly and efficiently run analyses. Additionally, the DataFit project was created to implement software to validate incoming clinical and pre-clinical submissions to ensure that data is fit for use by these modern review tools. The software that drives the FDA DataFit project is Pinnacle 21 Enterprise.

The Proof is in the Numbers

The numbers are in. And, it appears that the FDA’s vision is proving to be a significant boon to the entire biopharmaceutical industry. Those who have been early adopters of the process, and its supporting technologies, are already reaping substantial benefits. Consider these two telling facts:

Fact #1: Drugs are being approved faster than at any time in the FDA’s modern history. By way of example, the average decision time on drugs by the FDA’s oncology group has been reduced from six months down to just five.

Fact #2: 2015 was a record year for new drug approvals. The total number of new drugs approved last year reached 51, which is the highest volume of new drug approvals in 66 years (since 1950).

In short, the need for, and benefits of, the new process are now proven and clear. The deadline for its adoption has been announced. Yet, as an industry, we’re a long way off from reaching the full potential of this modern regulatory review process.

Where We Stand

Since 2014, clinical trial data submitted to FDA that received JumpStart service has been loaded into Janus Clinical Trials Repository (CTR). The Janus CTR provides reviewers with easy access to this data, which, in turn, supports efficient regulatory review. However, for this to work, the data in question has to be both compliant and useful.

Alarmingly, 77% of all studies failed to load on first attempt.

There are many different reasons for the various load failures (e.g., missing or issue-laden Define.xml files were a big contributor; here is a list of common load errors). But this 77% failure rate is indicative of an industry that is not ready for December 17th. Beyond that, it’s indicative of lost opportunity. What does this all mean? In a nutshell, it means that being 100% ready for submission — which requires the validation of your data against FDA requirements — is of paramount importance, now more than ever. It also means that if you want to be sure you’re doing it right, why not leverage the same tools used by FDA to validate data: Pinnacle 21 Enterprise. If you would like to discuss the modern regulatory review process and see the technology that drives the DataFit project at FDA, contact us to schedule a demo of Pinnacle 21 Enterprise.


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