To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA’s requirements for approval of the product
In this eClinical Forum webinar presentation, Dr. Jules Mitchel, President of Target Health, facilitated the discussion on the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.
Dr. Jules Mitchel at NY Medical College, October 2014
Nobody wants to receive a Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be "the end of the world."
Target Health, Inc. participated in study design, regulatory activities, and data management, and reviewed all versions of the manuscript for this clinical trial.
Interaction is high on FDA’s list of ways to improve the development and review process for technologies.
Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs.
