Investigator Beware: When Research With Marketed Drugs Calls for INDs

March 30, 2012

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.

How do you make sure you are up to date with clinical investigator compliance? It’s as simple as a click. Get your copy of FDAnews’ Managing Clinical Investigator Compliance: A Guide to the FDA Requirements.

By ordering this copy, you’ll also get your hands on a complete overview of the core requirements of the FDA “investigator responsibilities” guidance and see which investigator tasks must be performed by medically qualified staff.

Stay in control, and stay compliant by ordering this book today!