New FDA Tools for Investigators and Clinicians

The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.

The Research IND (Investigational New Drug) Pilot Portal is a web-based tool for submission of non-eCTD (electronic Common Technical Document) Research INDs. The submission process is streamlined by using dynamic and intuitive questions with targeted links, resources, and CFR guidance. The tool provides user-friendly capabilities such as auto population of Form FDA 1571, reusable data, and a centralized dashboard to track all submissions. Digitizing non-eCTD Research IND submissions into an electronic, structured format will alleviate the amount of PDF/paper submissions FDA receives and thereby increase FDA review efficiency.

Expanded Access eRequest is a web-based tool that enables physicians to complete, sign, and submit non-emergency Expanded Access (EA) requests to FDA. EA eRequest helps physicians determine whether EA is appropriate for their patients, walks physicians through the process of completing Form FDA 3926, and provides useful links and resources. It is hosted by the Reagan-Udall Foundation for FDA and was developed with input from FDA.