FDA Guidance Blog #5 - Laura Salomon

Name of Guidance:
Guidance for Industry – Providing Submissions in Electronic Format – Receipt Date

Status of Guidance/Release Date:
Providing Regulatory Submissions in Electronic Format – Receipt Date is a draft guidance, dated June 2007.

Link to the Guidance:
The guidance can be found at the following location:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072385.pdf

Target Audience:
Receipt Date is one guidance in a series that the FDA is developing for sponsors to reference when submitting electronic applications. The target audience, therefore, includes the sponsor and any employees involved in formatting, assembling, and/or submitting electronic documents, as well as any who ensure regulatory compliance of these electronic submissions.

Laws and Regulations Referenced:
21 CFR 312 Investigational New Drug Application

Prescription Drug User Fee Act of 1992 (PDUFA) – allows the Agency to collect fees from companies that manufacture certain human drug and biological products

Summary:
The purpose of this guidance is to clarify what the FDA considers the receipt date for electronic submissions, which include eCTD (electronic common technical document), non-eCTD electronic submissions, and hybrid submissions to CBER and CDER. The receipt date of a submission is often used by the FDA to determine regulatory milestones, such as the 30-day safety review cycle for an IND or a review performance goal date for an NDA or BLA.

For a completely electronic submission, such as a submission on CD-ROM or in eCTD format, the official receipt date is the date the submission arrives at the appropriate document room or transmits through the electronic submission gateway (ESG). For a two-part submission, in which part is in paper and part is electronic, the receipt date is determined separately according to when each part is received.

The FDA asserts that occasional technical problems (e.g. defects in media, improper sequence numbering, presence of a virus, etc) that prevent reviewers from opening, processing, or archiving information will often interfere with and delay submission review; it cannot begin until all technical issues are resolved.

The FDA changed its policy to encourage technically valid electronic submissions: the Agency will consider a technically deficient application not received until all problems are corrected and the application properly resubmitted. Any submission must pass a technical validation to ensure it can be opened, processed, and archived before the receipt date is confirmed. Once a submission passes this validation process, the assigned receipt date is the business day on which it arrives at the appropriate document room or is received through the ESG.

Rationale:
The FDA changed its policy on receipt date to encourage applicants to ensure that their electronic submissions are free from technical issues. Technically sound submissions allow the FDA to begin the review process promptly and without problems.

Resulting Recommendations:
The FDA recommends that sponsors become familiar with the technical specifications an electronic submission must pass; these specifications are posted on the Agency website, and they describe the validation checks performed on each type of submission in electronic format. Sponsors and applicants who are inexperienced in submitting electronic applications should request technical assistance.


Impact:
The transition from paper to electronic submissions has had a major impact in industry. In general, electronic submissions are both created and reviewed faster, and they are quickly becoming the standard format in the United States and worldwide. Because this guidance attempts to guarantee technically sound electronic submissions and establish clear definitions of receipt date, sponsors should be more confident that their submissions are received and important regulatory milestones can align with company-established timelines.