July 22, 2019What's New
Target Health Inc., established in 1993, has been inspected twice by FDA as part of pre-approval inspections. The first inspection was for a drug and the second inspection for a De Novo 501(k) device. In both cases An FDA 483, Inspectional Observations, was not issued to management during these inspections.
In one of the inspections FDA completed a 4 day, unannounced inspection of Target Health for an NDA under review. For this program Target Health performed all of the clinical and regulatory strategic planning, toxicology, regulatory, study designs, monitoring of the clinical trials (Phase 1, 2 and 3), data management (using Target e*CRF EDC system), statistics, medical writing and preparation of the NDA. There were 2 pivotal trials and a rescue protocol for treatment failures. The FDA audit also included a detailed review of Target e*CRF and data management. The outcome of the inspection is summarized below:
From our evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor