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  1. Electronic Regulatory Submission and Review

About FDA's Data Standards Program Transcript

FDA’s Data Standards Program helps get everyone in the drug development process speaking the same language.
 
This short video explains some new requirements for submissions to FDA.
 
Data standards are like sheet music. Without standard notes, rests, and parallel lines, it doesn’t make sense.
 
Data standards are the scientific parallel, allowing everyone to sing the same tune.
 
Some data standards have been required for years. Take Structured Product Labeling.
 
It’s a standard way for manufacturers to record product and facility information and share it with FDA. It’s been required since 2005.
 
Anyone can look up electronic drug labels and easily find information like side effects, because every label is organized in a standard format.
 
Other requirements are new. Starting in May 2017, many regulatory submissions to CDER and CBER have to be made in the Electronic Common Technical Document format.
 
You don’t have to send old submissions in again. But anything new has to use eCTD. That includes new submissions to old applications, like amendments and reports.
 
FDA is also introducing new requirements for standardizing the data that comes out of studies.
 
Once a requirement goes into effect, data from most studies that start after that date will have to follow those standards.
 
More standards will be coming soon. The Data Standards Program is “tuned in” to partners in industry and standards development organizations.
 
Eventually FDA will have data standards in areas such as identification of medicinal products, pharmaceutical quality, manufacturing, and more.
 
All the information you need is right on our website. Look up our guidance documents for the final word on data standards requirements.
 
Our website also has technical conformance guides. The Data Standards Catalog is where you can see the most up-to-date information on what formats we accept.
 
And you’ll find links to presentations about data standards by people here at FDA.
 
Data standards are helping FDA streamline and modernize the drug review process.
 
With data standards, reviewers don’t have to spend as much time organizing data, so they can concentrate on using the data to review the safety and efficacy of drugs.
 
One example is a program called JumpStart. When we receive data in standard formats, JumpStart helps the reviewer get…well, a jump start on the review.
 
JumpStart can assess clinical trial data quality. It can perform exploratory data analysis. And all of this at the very beginning of the review process.
 
Reviewers say it’s already giving them more confidence in how the submitted data will support their decisions.
 
And drug sponsors like that reviewers can alert them to potential issues early.
 
Data standards are a big step forward for drug development. Requiring data standards is one way FDA keeps its commitment to bring new drugs to the public—
 
and will help researchers answer new questions about the medicines we take.
 
With data standards, everyone from basic researchers to clinicians to FDA reviewers can keep in sync.