FDA’s voluntary pilot project that introduced industry to an automated form for field alert report (FAR) submissions has been successful. The following objectives of the pilot project, which launched in May 2013, have been met: (1) allow simultaneous reporting to FDA’s Office of Regulatory Affairs (ORA) district offices and FDA’s Center for Drug Evaluation and Research (CDER), and (2) determine the feasibility of transitioning from a simple PDF to a functional PDF with automated processing using extensible markup language (XML).Use of the automated form has improved the speed and efficiency of reporting on product quality issues related to the manufacture of drug products approved under a new drug application (NDA) or abbreviated new drug application (ANDA) by FDA.
With the end of the pilot project on June 15, 2017 , FDA is making a new version of the automated form—Form FDA 3331a—publicly available on its website (see FDA’s Field Alert Reports Web page ). The new version of Form FDA 3331a incorporates feedback from pilot project participants. FDA encourages all of industry to use this new automated form to submit FARs for both CDER and Center for Biologics Evaluation and Research (CBER) regulated drug products approved under an NDA or ANDA.
The main differences between the form used during the pilot project and the new version follow:
- Most fields are expandable, eliminating the need for continuation pages.
- Some of the fields have been rearranged.
- The lot number and expiration date fields have been combined.
- The dosage form and strength/package size data are now in separate fields.
- The problem and reporting firm sections now have separate fields for individual address components.
- A DUNS or FEI number is now requested for the reporting firm.1
- Signatures are not required.
- Industry may use the new version to submit FARs for NDA and ANDA drug products that fall under the jurisdiction of CDER or CBER.
Beyond Adobe Acrobat Reader and an email client, no additional software or licenses are required to use Form FDA 3331a. With the release of this updated form, which uses XML, FDA can import FAR data directly from the XML files.
For FAR reporting requirements related to NDAs and ANDAs, see 21 CFR 314.81(b)(1).
Form 3331a is part of our continuous efforts to improve the FAR submission process. We are aware that the electronic Common Technical Document (eCTD) technical specifications for Module 1 include a section for FARs. FDA is currently working on the technical requirements for receiving FARs as part of the eCTD through the Electronic Submissions Gateway (ESG) and will provide additional information on this process in a future guidance. At this time, FDA requests that firms do not submit FARs using the ESG, but instead follow the procedures provided on FDA’s Web page for using Form FDA 3331a.
For additional information, questions and answers, and to access the form, see FDA’s Field Alert Reports Web page.
1DUNS=Data Universal Numbering System; FEI=Facility Establishment Identifier.