Changes to Training Requirements for ORA’s Basic Investigator and Medical Device Investigator Training Programs

FDA investigators at work (collage overlayed with the FDA logo)In accordance with Article 3, Section 2B, of the CBA, FDA provided notice to NTEU of the Office of Regulatory Affairs’ plan to change the training requirements for the Basic Investigator and Medical Device Investigator Training Programs.

NTEU has requested a briefing to gather additional information about the new training requirements and to determine whether there are any negotiable issues.

I welcome and encourage your feedback on this change.