Technical Standards for Electronic Submissions: FDA Opens Public Consultation


Posted 15 June 2018 | By Michael Mezher 

Technical Standards for Electronic Submissions: FDA Opens Public Consultation

The US Food and Drug Administration (FDA) on Friday launched a public consultation on its publication of technical specifications for electronic submissions for premarket drug and biologics submissions.
 
Specifically, the consultation covers the agency’s publication of technical specifications that explain and define the use of data standards used in new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) and certain investigational new drug application (IND) submissions to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics License Evaluation (CBER).
 
Background
Section 745A(a) of the Food, Drug, and Cosmetic Act, as added by the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, established a requirement for electronic submissions for most premarket submissions for drugs and biologics, no sooner than two years after FDA issues guidance detailing the format for those submissions.
 
In 2014, FDA finalized its guidance Providing Regulatory Submissions in Electronic Format—Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act, which discussed the agency’s interpretation of Section 745A(a) and explained that specific technical specifications for the various submission types would be detailed in individual guidances and technical guides.
 
Consultation
 
For the public consultation, FDA says it is interested in getting input from stakeholders on “any matters” relating to the use of technical specifications.
 
“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,” FDA writes in the Federal Register notice announcing the consultation.
 
FDA notes that it is looking for input on all its technical specifications documents for electronic submissions, but says it is not seeking comments on issues covered in other public dockets.
 
Federal Register Notice

Categories: Regulatory News



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