FDA Guidance on
Providing Regulatory Submissions in Electronic Format — Receipt Dates
In February 2014, the FDA issued a guidance to assist sponsors, applicants, and others
making regulatory submissions in electronic, paper, or hybrid format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER).
The guidance
eliminates the 4:30 PM cut-off for electronic submissions received through the
electronic submission gateway (ESG) Monday through Friday. Electronic
submissions submitted up to 11:59 PM will now be assigned a receipt date
corresponding to the same day of submission.
The FDA states that a regulatory submission’s receipt
date is the date on which the submission is deemed to have arrived at the FDA.
The receipt date may be used to determine important regulatory milestones, such
as the end of the 30-day safety review cycle and the review performance goal
date.
A paper submission is assigned a receipt date
corresponding to the day on which it physically arrived at the appropriate
receiving unit of the FDA center designated to review the submission, while the
office is open for business.
Contact RPI to find out how
your company can use electronic publishing to streamline
the FDA submission process.