Browsing FDA Data and Resources

Where do I find…?

When it comes to searching and navigating the FDA site, some information is deeply nested or buried under several sub-pages.

Within this article is a list, with hyperlinks and captions, of many of the FDA’s offerings in terms of the compliance data they offer publicly and some of the education-based tools.

The focus will remain specifically on links and resources regarding drugs, devices, and biologics.

“The FDA created the Data Dashboard to increase transparency and accountability by displaying and allowing the analysis of public FDA data through easy-to-use, visually accessible, customizable, and understandable graphics.”

The FDA Data Dashboard

• Inspections
• Compliance Actions
• Recalls
• Imports Summary
• Import Refusals
• Imports Entry

Through the FSMA Data Search

• Firm Information: this is the best way to search for a company and/or FEI #. Note that when searching companies with many locations or subsidiaries, it may be difficult to locate, and you should enter the most general name.
• LAAF Participants
• TPP Participants
• Approved VQIP Importers

The FDA Data Dashboard API Usage and tutorial

The above page details all of the requirements and features of the API that the FDA provides for the links above in the FDA Data Dashboard.

Note that for all of the above, the applicable FDA Contact is FDADataDashboard@fda.hhs.gov.

FOIA Requests

Specific information or documents can be requested from the FDA; there are several points of contact,

FOIA, Freedom of Information Act Requests provide “publicly accessible “electronic reading rooms” with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features” — Source.

You can make a FOIA request online or visit in person at 5630 Fishers Lane Rm 1061, Rockville, MD 20857, M-F, 9am- 4pm.

It’s important to note that the requestor’s information and request are made public here.

Frequently requested documents and other links. Furthermore, frequently requested documents are then displayed locally, here through dashboards for

• FDA Warning Letters
• FDA Compounding Inspections
• FDA Foreign Manufacturing Sites Inspection Records
• FDA Enforcement reports specifically the weekly updates. Also, find out how to subscribe to the mailing list here.

Learning Tools

The FDA provides tools for specific purposes; this section mainly focuses on what the office provides to assist firms in preapproval diligence. Find some of these resources written about in detail here.

Find FDA Guidance Documents, comprehensive beyond devices.

Catalog of regualtory science tools.

Overall FDA Learning Tools.