Signs Point to Stricter Enforcement of FDA Fillable Forms

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In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 36741. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically.

Using industry presentations and guidance documents2, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.”

Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.

A complete list of FDA fillable forms is available here. As best practice, you’ll want to routinely consult this landing page for your forms to ensure that you’re obtaining the most current versions, as opposed to using a version saved locally. A quick check shows that many of the commonly used forms have been recently updated.

In response to an inquiry on the specific fillable forms signed electronically this requirement applies to, FDA eSubs responded “At this time it is limited to 1571, 356h, and 2252. However, this could be expanded in the future as we automate more processes.”

A contradiction exists between the classification of the validation error for including fillable forms (error 5025, Low severity) and FDA rejecting submissions. However, it is not unusual for published documentation to lag behind FDA enforcement in practice.

FDA’s Automated Processing of eCTD Submissions

In recent years, the FDA has made numerous mention of its efforts to automate eCTD submission processing. What exactly does this mean and what role do fillable forms play? Here is a list of automatic processing steps FDA systems perform upon receipt of a submission.

1. Opens the submission

2. Reads the application number on the fillable form

3. Confirms the application number read on the fillable form matches the application number recorded in the FDA’s tracking system

4. Runs GlobalSubmit VALIDATE to check for all error conditions listed in the latest FDA validation criteria and confirms that the application number listed in the application form matches the application number that appears in the XML

5. If there are high errors, the submission is automatically rejected. Otherwise, the FDA system sends a confirmation communication noting that the submission has passed validation

Background: Electronic Submission and FDA Fillable Forms

FDA fillable forms have existed for some time, but now with the advent and modernization of the Electronic Submissions Gateway (ESG), these forms are the lynchpin that enables automatic processing of submissions. The FDA’s system processes a fillable form, interprets the information, and then routes the submission to the proper individual or department. If you elect not to use fillable forms, an FDA representative must manually examine documents to determine the proper routing of a submission.

FDA fillable forms include certain mandatory fields that must be completed. These field are blue-gray in appearance. If they’re not populated with information, the user receives an error message that details what’s missing.

FDA Fillable Forms

Best Practices for Electronic Signatures on FDA Fillable Forms

Once you’ve entered the required information, the person in your organization responsible for signing the form simply clicks the “sign” button. Adobe self-sign capability is the easiest way to deploy FDA fillable forms. Your information technology department or technology partner should be able to help set this up.

Pay Attention to Details

There are a few important housekeeping details you’ll want to pay attention to when completing FDA fillable forms. First, a sponsor must have a letter of non-repudiation on file with FDA. This traditional paper letter simply states that your organization recognizes electronic signatures to be as binding as hand-written signatures. Details steps on submitting a non-repudiation letter can be found here.

You’ll also want to double check that your forms and cover letter (if applicable) match in terms of application number and application type. Mismatched information could delay the Agency uploading and processing your submission; technical rejection is also a potential consequence. You or your eCTD vendor should also verify that the application number of type of your “us-regional.xml” and fillable forms line up.

The FDA recently announced CDER will begin issuing a 3rd ESG acknowledgement your submission successfully completed validation and processing. This is facilitated by use of fillable forms.

Overall, these are not difficult benchmarks to meet. Utilizing FDA fillable forms is straightforward and is the number one way to quickly and effectively get your submission into the hands of an FDA reviewer.

Stay Tuned

As FDA clarifies best practices for fillable forms/electronic signatures and updates validation specifications, we will share information with industry on the eCTD Summit.

References

1 Requirement to submit FDA fillable form 3674 is based on FDA Guidance on Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402 (j) of the Public Health Service Act requires applicants to complete and submit Form 3674 with IND, new protocols to IND, NDA, efficacy supplements to NDA, BLA, efficacy supplements to BLA, ANDA, PMA, HDE and 510ks that involve a clinical trial.
2 The most current guidance regarding FDA fillable forms issued May 15, 2015 – Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – states that “electronic submissions must include only FDA fillable forms (e.g., 1571 or 356h) and electronic signatures to enable automated processing of submissions.”

Author: Rob Labriola

Rob Labriola has 20 years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understand the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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