September 3, 2019What's New
Rare and Orphan diseases is one of the strengths of Target Health Inc. These programs require regulatory strategic planning as well as carefully designed clinical trials. Early in development, even before the IND is open, we often submit Orphan Drug Designation (ODD) requests based on non-clinical data. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated. Once the IND is open, we submit Fast Track designation requests that allows for a more active interaction with our colleagues at FDA. Where there are validated biomarkers of disease, we assess a path to Accelerated Approval, followed by a confirmatory study.
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