U.S. FDA· FDA·· 4 hours agoPickScore58
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle
In brief
FDA's Center for Drug Evaluation and Research has issued a final Level 2 guidance specifying the technical specifications for submitting clinical trial data used to evaluate the ability to operate a motor vehicle in support of marketing applications for drugs or biological products.
Why it matters
The guidance specifies driving-study data submission structure down to the field level, giving sponsors a directly usable template for preparing driving-ability data in marketing applications.
Source: U.S. FDA