FDA

January 16, 2023

In December 2022, the Food and Drug Administration (FDA) published an updated version of its Validator Rules. Pinnacle 21 Principal Consultant Michael Beers delivered an overview of the differences between newly released version 1.6 and the now legacy March 2021 version 1.5.

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September 10, 2021

The COVID-19 pandemic had an immense impact on people’s lives. The quick development of effective and safe vaccines as well as their availability are critical to public health.

Clinical trials for vaccines typically collect similar types of data. Preparing this data for submission requires knowledge of specific guidance from regulatory agencies and standards development organizations. In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance and other considerations for preparing vaccine studies for regulatory submissions. Also, Michael goes over common problems and inconsistencies seen in data of vaccine studies.

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September 13, 2020

In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit, the agency’s implementation of Pinnacle 21 Enterprise.

The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine. It will be available for the next few months until our next release. This window allows you to finalize your ongoing submission preparations.

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June 11, 2020

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.

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June 5, 2020

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.

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April 2, 2019

Released March 31, the new P21 Enterprise 4.0 provides more options for submitting study data to the Japanese health authority PMDA, plus better ways to manage validation issues and reports, as well as new validation rules and support for STDMIG 3.3.

P21 Enterprise 4.0 addresses concerns raised by our customers who submit data to both FDA and PMDA. Historically, regulators at the two agencies have embraced clinical data standards and conformance rules at different rates and degrees of severity.

Running data validations for PMDA has required a separate compliance strategy, plus extra time for validation and regulatory submission. Too often, sponsors worry that PMDA submission packages will fall short of reviewer expectations.

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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?

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July 5, 2017

Pinnacle 21 recently hosted a webinar discussing the FDA’s new business rules for clinical data. You can watch the video, access the slides and review the Q&A list.


Webinar Video

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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:

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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.

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