Beefed-Up Rule on Investigator Disqualification Takes Effect This Month

An FDA final rule with stronger restrictions on the work of disqualified trial investigators will take effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback. Under the tighter policy, clinical investigators who are deemed ineligible to receive one type of investigational product, whether it is a drug, device or animal drug, would also be ineligible to partake in studies supporting applications for any FDA-regulated products.
Washington Drug Letter