Improving Access to Publicly Available FDA Information

The FDA houses a wealth of authoritative information that, if more accessible through other communication mechanisms, could improve medical product use, as well as research. Just as the NOAA-collected information helps to better inform researchers and the public, making FDA-held publicly available data more accessible could help the public and researchers access real-time changes about FDA-regulated products.

The project set out to discover what patients, caregivers, healthcare professionals, and researchers want to know about FDA-regulated medical products (drug and biologics); where they seek this information; what FDA data are publicly available for external sources to utilize in generating query responses.

We synthesized our findings on patient, consumer, and healthcare provider behavior in seeking information as well as what information sources exist on the FDA’s website. The report includes a catalog of FDA’s publicly available information, including detailed information on dataset metadata, which refers to data about the data, such as the structure, format, content, and other characteristics of these datasets, of various FDA databases, including Drugs@FDA, the FDA Adverse Event Reporting System (FAERS), the Product Labels Database, and the National Drug Code (NDC) Directory, and more.