News has been hitting all over the regulatory blog sites, but in case you haven’t already seen this, the FDA issued a final regulation earlier this week (April 30th) that broadens the rules for clinical investigator disqualifications. Previously, if an investigator (clinical-investigator or sponsor-investigator) was determined to be non-compliant and ineligible to receive clinical trial material such as an investigational drug product, the disqualification was only related to drug products. When the new final rule takes effect on May 30th, an investigator who is disqualified from conducting clinical trials in support of a marketing application for one type of product (i.e., a drug product) will also be disqualified for conducting clinical trials of any FDA-regulated product (i.e., biologics, devices, animal drugs, foods, etc…).
In response to earlier comments to the proposed regulation, the Commissioner clarified that disqualification of an investigator may result from multiple violations within a single study as well as single violations in multiple studies. Additionally, the FDA indicated that there were no time limits on how far back the Agency may investigate applications and submissions in which a disqualified investigator may have participated.
FDA will continue to post enforcement actions on its website, and it will also continue to allow disqualified investigators to become eligible to participate in clinical trials again once they have provided the Commissioner with adequate assurance for future compliance.
- Senator Hagan’s TREAT for Small Biotech (ask-cato.com)
- After all the talk, where are we with biosimilars? (ask-cato.com)
- The CED Life Science Conference and Biotech’s Yellow Brick Road (ask-cato.com)
- HHS Proposes Changes to HIPAA (ask-cato.com)