FDA Seeks Comments on Technical Standards for Electronic Submissions

June 19, 2018

The FDA launched a public consultation on its technical standards for electronic submissions of abbreviated new drug applications, biologics license applications and certain investigational new drug applications.

The public docket requests feedback on the agency’s technical specifications, which explain the specific use of data standards in the applications. The feedback should be related to specific technical specification issues, or general technical specifications that are not specific to documents or issues covered by other dockets.

“This information will give the Agency insight into stakeholders’ experiences and views regarding the use of technical specifications guidances and the data standards they contain,” the agency said.

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