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In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.
Topics: FDA Inspection, Brexit, CISST Algorithm
You just got the phone call; the Food and Drug Administration (FDA) Inspector is coming for a visit.
Topics: FDA Inspection, BIMO Inspection
Are you feeling calm and prepared, or like most people in your position, are you in some stage of panic? After all, who wants someone from the federal government looking for (and inspecting!) all the things you might have done wrong?
Topics: FDA BIMO inspection, FDA Inspection
While inspections of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO Inspections can occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be challenging to predict as the audits are not necessarily triggered by a sponsor regulatory submission.
Topics: IMARC Whitepaper, FDA Inspection, BIMO
When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.
Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”
Topics: Charles Selfe, FDA Warning Letters, FDA Inspection
Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.
Topics: FDA Audit, FDA Inspection, BIMO
With the trials IMARC Research has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. However, on one of the projects we were working on FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted.
Topics: Medical Devices, Premarket Approval Application, FDA Inspection