New Free Regulatory Research Tool
Wondering how to prepare for the regulatory pathway your product will follow in the US?
The IRAI Digital Repository is a resource that provides free access to public domain information about FDA and its regulated technologies. For hints on how to use tools like this website effectively, watch theNHLBI Small Biz Hangout "Developing a Target Product Profile".
The objective of IRAI Digital Repository is to provide an improved platform and search engine for anyone doing serious research on FDA-regulated products. 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. 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.).