Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in the form of regulatory insight and operational efficiency as you navigate the FDA apparatus.
eCTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reformatting. High-quality documents are a precursor to successful submissions. Leveraging templates is one way to help make this possible.
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.
Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.
A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.