DIOGENES.

Area of Science:

• Biomedical Informatics
• Regulatory Science
• Health Information Management

Background:

• Access to comprehensive regulatory information is crucial for drug and medical device development.
• The Food and Drug Administration (FDA) provides extensive regulatory data.
• Efficiently navigating and utilizing FDA data presents a significant challenge.

Purpose of the Study:

• To describe the DIOGENES database, a resource for FDA regulatory information.
• To highlight the specific strengths and capabilities of the DIOGENES database.
• To outline planned enhancements for the DIOGENES database.

Main Methods:

• The DIOGENES database aggregates drug and medical device regulatory information.
• Information is sourced from the Food and Drug Administration (FDA).
• The database is accessible through BRS Information Technologies.

Main Results:

• DIOGENES provides a centralized repository for FDA drug and medical device regulatory data.
• The database's current strengths in information retrieval and organization are detailed.
• Specific areas for future development are identified to improve functionality.

Conclusions:

• The DIOGENES database serves as a valuable tool for accessing FDA regulatory information.
• Its current features offer significant benefits to users in the pharmaceutical and medical device industries.
• Ongoing development aims to further enhance the utility and scope of the DIOGENES database.