FDA Standards for Electronic Submissions
The Electronic Records; Electronic Signature Rule (21 CFR Part 11), or "the Esig rule," is the US law that provides FDA the authority to identify types of submissions that the agency will accept in electronic form. The Esig rule also states that persons should consult the agency for details on how to proceed with electronic submissions. Such details include method of transmission, media, file formats, and technical protocols. The FDA issues guidance documents to reduce the need to consult for details.
In January 1999, the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) issued a joint guidance on general considerations for electronic submissions, entitled Providing Regulatory Submissions in Electronic Format - General Considerations . The guidance describes the use of the SAS System XPORT format for electronic data sets.
The FDA plans to issue a series of guidance documents that will focus on specific submission types. The first of this series was issued in January 1999, when CDER issued a guidance on NDAs, entitled Providing Regulatory Submissions in Electronic Format - NDAs .