The document explains the FDA’s current thinking about studies that should be conducted to show that a proposed drug has abuse-deterrent properties. The FDA said those studies will be evaluated by the agency and laid out which labeling claims would be approved based on the results of those studies.
“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” said FDA Commissioner Margaret A. Hamburg, MD. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”
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