FDA

FDA Validator Rules 1.3 Released

November 12, 2018

Last week, FDA published an updated version of Validator Rules for study data. There are many changes which we have reviewed and summarized for you.

The first change you’ll notice is that there are a number of new columns:

  • FDA Validator Rule ID – a unique rule id that is now consistent across FDA, PMDA, and Pinnacle 21
  • FDA Validator Message – validation messages produced by the Validator
  • Publisher – the source of the business or conformance rule, FDA or CDISC

The FDA list now includes the conformance rules published by CDISC, which is the why the list has grown by 317 rules, from 163 to 480. The CDISC rule ids can be found in the Publisher ID column.

Next, the FDA added a reference to SEND-IG 3.1 to show how existing business and conformance rules apply to this standard. CDISC is still working on the conformance rules for SEND-IG 3.0 and 3.1, so this list could serve as a guide for implementers for the time being.

So how does this release effect you?

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

July 25, 2016

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December 17, 2016, is less than five months away.

As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.

To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.

With time running out quickly, two big questions have taken on a new urgency:

Are You 100% Ready for FDA Submission?

March 7, 2016

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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.

The History of OpenCDISC

February 24, 2015

In the Beginning

It was late 2007. Mad Men was the hottest show on TV. The BlackBerry was still the most popular smartphone. Senator Barack Obama was securing his party’s nomination for the next presidential election. And a young clinical data exchange specialist named Max Kanevsky was contemplating the future of the biopharmaceutical industry.

During his tenure at Merck, Max had been responsible for integrating the company with many external partners (e.g., laboratories, CROs, joint ventures, technology providers), working with many non-standardized sources of data. Though the norm, gathering all that disparate data and mapping it into Merck’s internal standard was a huge challenge. When the Clinical Data Interchange Standards Consortium (CDISC) started to make headway in its mission to develop a global set of standards, it marked a new beginning. CDISC would eventually define the standards for the entire industry.

But Max wondered how sponsors would possibly manage such a sea-change. At the time, software options to help ensure a submission’s compliance with FDA business rules were limited. WebSDM offered limited performance and capabilities, at a price point that was prohibitive to many. Meanwhile, Max was helping Merck with its early manual implementations of CDISC standards, including LAB, ODM and SDTM, which were difficult and time consuming. And each new challenge provided an obstacle that could threaten FDA approval of any given drug. There had to be a better way. But what?

FDA Final Guidance on Study Data Standards Webinar — Recap

January 25, 2015

It was a long time coming. But, finally, on December 17, 2014, the FDA announced that applications must be submitted electronically, and that submissions will be required to contain study data in conformance with CDISC standards.

The industry has been given 24 months from the publication of the final guidance documents to comply. Not wanting to waste any precious time, Pinnacle 21 hosted two webinars — on January 7th and 8th, 2015 — to help guide you through the new processes.

FDA JumpStart: an introduction

July 16, 2014

High Quality Data

You’ve probably heard of JumpStart by now. The FDA is describing it as a “service [that] is modernizing the drug review process.” But how, and why? And how can the pharmaceutical and biotech industries benefit from it?

One of the big drivers of this change was time. Currently, when the FDA receives a submission, reviewers spend up to 45 days just to assess the quality of that submission. They have to first churn through enormous files — some of which are gigabytes in size — to determine if the data quality and content are strong enough to support the review. Between the time spent by the FDA to conduct this “pre-review,” and the time spent by the submitting organization to fix these issues and resubmit, valuable months are often wasted.