Target Health Blog

The NIH CounterAct Program and FDA's Animal Rule

March 11, 2019

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Before a medical product can be approved by FDA, the sponsor must prove efficacy showing that the product works. In some cases, such as developing medical countermeasures (MCMs) for potential bioterror threats, human challenge studies (exposing people to the threat agent) would not be ethical or feasible. In these cases, FDA may grant approval based on well-controlled animal studies, when the results of those studies establish that the drug or biologic product is reasonably likely to produce clinical benefit in humans. The product sponsor must still demonstrate the product's safety in humans.

The 13th Annual CounterACT Network Symposium brings together chemists, toxicologists, drug developers, pharmacists, clinicians, and public health researchers, and offers NIH CounterACT scientists the opportunity to present their latest research findings for the purpose of sharing this information with their fellow researchers and Program Officials.

Target Health is very pleased that Dr. Jules T. Mitchel will presenting a keynote presentation at this year's Symposium, being held on June 18-20, 2019 at the New York Academy of Sciences. across from the World Trade Center. The presentation is entitled “Working with the U.S. Food and Drug Administration to Obtain Approval of Products under the Animal Rule.“ Our good friend and colleague, Dr. Jeffrey Laskin is the overall director of The Rutgers CounterACT Center.

The CounterACT program supports basic and translational research aimed at the identification of better therapeutic medical countermeasures against chemical threat agents, and facilitates their movement through the drug development and regulatory processes in collaboration with other federal departments, agencies, and initiatives, such as the Biomedical Advanced Research and Development Authority (HHS BARDA) and the FDA Medical Countermeasures Initiative (MCMi). CounterACT is part of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which coordinates MCM-related efforts across HHS and USG interagency partners. This NIH-led program includes a comprehensive network of Research Centers of Excellence, individual co-operative research projects, small business innovation research grants, contracts, and interagency agreements with the Department of Defense.

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

Jules Mitchel, Editor

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