Superior Coverage

The database includes all FDA Warning Letters, Untitled Letters, and Cyber Letters — plus Determination Letters issued by the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) — dating back to July 1982.

One Central Location

• The FDA archives its past Warning Letters — meaning that letters before a certain date are no longer available through the agency’s search function.
• FDA Untitled Letters — including important Untitled Letters issued by the agency’s Office of Prescription Drug Promotion (OPDP) dealing with the advertising and promotion of human prescription drugs — are scattered over many other locations on the FDA’s website.
• Thompson’s FDA Enforcement Letter Database allows searching for all these letters — and all other FDA enforcement letters — using a single interface.

Advance Search Capability

Thompson’s FDA Enforcement Letter Database’s advanced search engine offers more ways to search, including:

• Letter text
• Letter date — on, before or after a specific date, or during a range of dates
• Issuer name — the specific FDA component that issued the letter
• Recipient company — the specific company name, or any words within the name
• Product category — narrowing your search to one of 13 product types
• Regulatory topic — letting you focus your search on your particular issue
• Alleged violation — providing a summary of the agency’s allegations
• Product name — brand name or product type
• Letter type — Warning Letter, Untitled Letter, Cyber Letter or Determination Letter