Investigator Beware: When Research With Marketed Drugs Calls for INDs
Studies of approved drugs that involve a different route of administration or dosage level that significantly increases the drug’s risks are not exempt from clinical trial investigational new drug (IND) regulations. Trials of these drugs must be conducted under an IND application, an FDA warning letter reminds researchers.
It’s a lesson clinical investigator Betty Tuller learned the hard way.
Tuller violated a multitude of requirements under 21 CFR Part 312 when she worked at Florida Atlantic University’s Center for Complex Systems and Brain Sciences, endangering the safety of trial subjects and compromising the integrity of the study, a 2011 FDA Bioresearch Monitoring Program inspection found. The researcher conducted five studies of a marketed drug that, despite the product’s approved status, needed to comply with IND regulations — measures she often did not take.
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