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The Pharma Marketing Glossary
An FDA Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of a Warning Letter. Untitled Letters are intended to cover those circumstances where the Agency has a need to communicate with regulated industry about violations that do not meet the threshold of regulatory significance. The three types of letters related to licensed products that are issued by CBER and CDER, pursuant to section 6.3 of these procedures, do not necessarily fall within this definition of an Untitled Letter; however, they are still Untitled Letters that are covered by the scope of these procedures.
Untitled Letters are less serious than the more widely-known Warning Letters, which indicate that failure to take action will lead to regulators taking enforcement action. Instead, the Untitled Letter calls for a correction (typically in an advertisement or other promotional material), but almost always stops short of indicating that enforcement action will be forthcoming if changes aren't made.
Where to find more information:- Source: FDA Regulatory Procedures Manual March 2010 (pdf)
- Audio source: FDA BadAd Program
