The objective of IRAI Digital Repository is to provide an improved platform and search engine for anyone doing serious research on FDA–regulated products. IRAI is a non-profit effort in education by MedData Foundation with the assistance of the United States Food and Drug Administration open to the public.
The IRAI repository initiated under a contract with the Food and Drug Administration has the objective of implementing a new system for cataloging FDA materials in an easily accessible and searchable format for research and training at academic universities and for all other stakeholders for research and training in FDA’s policies and procedures.
IRAI is a full-fledged information system, not just a website, with a well-organized table of contents that is browsable like a textbook. It has an excellent search and retrieval system using the latest version of Rocket Folio/NXT. IRAI will provide access to primary information resources and training materials of the Food and Drug Administration and other agencies that concurrently regulate aspects of the same products (e.g. USDA, FTC, CPSC, etc.).
• Structured access to all the information on the Food and Drug Administration website organized with a table of contents; additional resources of FDA not on its website, relevant materials from NIH (with resources of other agencies, being added for products regulated by FDA); and secondary analytical text materials from the Congressional Research Service.
• Platform's available to other newsletter and text publishers and educational organizations so that their materials (text and webinars) will be simultaneously searchable with the treasure trove of FDA documents thus facilitating the ability to avoid searching multiple websites or proprietary databases;
• Array of user-friendly features such as templates to guide one with Boolean searches; an Advanced search template that permits one to narrow search to specific categories and subcategories of information;
• An optimized simple interface for most personal computers, tablets, and mobile devices;
• An updated version of the software system most notably used by several states and the California Bar’s OnLaw;
• A user manual to help you with IRAI (which you may download here) as well as several short YouTube online tutorials developed by OnLaw: Browse, Search, Review Results, and Print. We will be adding our own tutorials in the next several months.
After you log on to IRAI-Live, you will see this screen.
You may also see items without volume numbers that we will integrate into the existing outline or make into a new volume.
While we designed, the repository to augment teaching and training curriculum of the public information resources, we will open it to anyone who wishes to do research in the vast collection of primary materials as well as licensed secondary materials that may also be simultaneously searched. Indeed any entity wishing to research concurrently their internal proprietary files will be able to search those files along with other IRAI materials. Thus, IRAI will provide users with the ability to access their resources in one place which will improve productivity by eliminating the need to have to examine multiple sites.
The benefits of this service distinguishes IRAI from other content storage or management options on the web or in other proprietary systems.
As stated in our contract with the FDA ”This proposal strives to address a challenge in providing FDA employees, regulatory science students and educators access to the extensive repository of FDA-related agency materials. This repository will not only provide a single source for academia, but guarantees that FDA has input in educating future regulatory scientists.”
Now, we are in Beta mode while we organize the hundreds of thousands of files.
When you register we will give you access to two versions of IRAI: IRAI: Live and IRA-FSE. Live contains the materials that we have added and restructured. FSE is a periodic “clone” of the FDA website (principally www.FDA.gov) using FDA’s Folder and Subfolder information storage structure for its documents. We create a clone so that items that we have yet to add to IRAI-Live may be found on IRAI-FSE with the same improved platform.
You are welcome to try the platform as it adds more data and give us your feedback as the ease of searching and other comments you may have. Just use the Sign-up sheet to get a user name and password.
We have also added a Comment box, in which you can tell us what you like and dislike about IRAI-Live, what additional FDA matter not on the FDA website that you want us to add, or other related public domain information. If it is public domain information it will always be there for free access.
Disclaimer. This notice represents the position of the author(s) and not necessarily that of FDA.
MedDATA Foundationis a 501(c) non-profit foundation dedicated to advancing the use of Information Technology in support of the mission of the United States Food and Drug Administration, its global partners, and the industries it regulates.
Our board consists of executives with long experience in FDA related matters and includes a former FDA Chief Counsel and a Senior agency manager.
Visit us at www.meddatafoundation.org for more information about our work.
Stephen Weitzman has been involved in healthcare matters for the past 45 years as a practicing lawyer and science consultant in the pharmaceutical, medical device, and food industries. He is a pioneer of the use of computers in legal and science research and litigations support systems from mainframe to personal computers.