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FDA Issues Guidance on Receipt Dates

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Today I am focusing on the FDA’s new guidance document concerning receipt dates.  Issued earlier this month, and entitled “Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Receipt Dates” (hereinafter “Guidance”), it relates to submissions made to the Food and Drug Administration.

Essentially, the Guidance describes the process for FDA’s assigning a receipt date for drug product submissions including, among other things, investigational new drug applications, premarket approval applications (e.g., NDAs and ANDAs) and adverse event reports.  FDA explicitly noted that the Guidance is not limited to submissions in the electronic common technical document format.

With regard to the substance of the Guidance, the receipt date is easy to calculate for e-submittals during FDA’s normal business hours – it will be the date that the Official Center Acknowledgement that is automatically sent to the submitter.  E-submissions made after business hours or on weekends or holidays will be deemed to have been “received” on the next day that the office is open for business.  Paper submissions will be “received” on the date of physical arrival at the appropriate FDA receiving unit.

Finally, technically deficient submissions will not be considered to be “received” until all deficiencies are corrected.