Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.
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 3674. 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 documents, 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.
FDA implemented eCTD validation criteria 2.2 on April 30, 2013. This version of the validation criteria includes PDF checks to ensure compliance with FDA PDF Specifications V2.0, Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications, ICH eCTD Specification V3.2.2, ICH Q&A, as well as promote general good practice to ensure reviewability.
Currently, a submission is loaded onto the Agency server and run through validation software. Error reports are then generated, and subsequently reviewed for legitimacy by a member of the FDA team. Once the fully-automated system is implemented, detection of a high-level error could meet the system’s threshold, and trigger technical rejection. A high-level error might simply be a case of misinterpreting FDA guidance, or using a publishing tool not updated with the latest validation criteria.
Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD. We...