By Mary Waters

Here’s Your Opportunity to be Heard

The Food and Drug Administration (FDA) has established a public docket so that anyone can share information, comments, and ideas on any matters related to the use of their technical specifications or technical specification guidance.

This is a great opportunity for those of you in the trenches to provide insight to the Agency about these specification/standards and if they are working or not for your organization.

What’s Behind Establishing a Public Docket

The Agency’s determined that it was not possible to describe and implement the electronic format(s) that could apply to every submission covered by section 745A(a) of the Federal Food, Drug, and Cosmetic Act in a single document. Instead, they created “standards” to explain their interpretations and to explain, clarify, and define the use of data standards used for certain submissions (new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs)).

By having established standards, the study data is uniform. This helps the Agency with being more effective and efficient in receiving, processing, reviewing and archiving submissions.

The Agency is interested in assisting sponsors in the submission of data in a standardized electronic format for NDAs, ANDAs, BLAs, and certain INDs. Both CBER and CDER have established technical specifications guidances which provide the thinking behind the established specifications, recommendations, and general considerations. These technical specifications explain, clarify, and define the specific use of data standards in regulatory submissions. In other words, the technical specifications break down the who, what, when, and where of the guidances.

Why You Should Comment

By providing your comments and viewpoints, this information gives the Agency insight into your (stakeholders’) experiences and views regarding the use of these technical specifications guidances and the data standards they contain. This may be a golden opportunity to make them easier to understand or apply to your data. And, that is a good thing in any industry!

Maybe you’ve found a specification or standard that is no longer relevant or just too complicated to use effectively. Or maybe you’re thinking about starting or have recently established your ESG account or secure email; this is where your input to the Agency is very valuable.

HartmannWillner Has Been There – Done That!

This link below will take you to the FDA’s Study Data Standards Resources web page that has all of the information, guidances, technical guides, position statements as well as business rules all listed in one place. You might want to bookmark this page for easy reference.

If after researching and reading, you still have questions and need answers, we can help you! We’ve been there and done that many, many times. Let us help you with any of your electronic publishing needs – we are just an email or phone call away!