Summary of IND Stages

The Company has already investigated the IND FDA approval process for Detoxamin®, including repeated contact with the FDA’s Small Business Assistance Director and in conjunction with our regulatory consulting firm.  A preliminary route of application was devised including most of the details elucidated below and has been modified following review by Dr. Evan Siegel, a member of the Company’s research team and a former FDA employee and a FDA consultant, who provided information and standards of excellence for reevaluating previous studies performed, guidelines and standards for manufacturing, testing, and clinical studies to be performed in the stages given below.  Dr. Siegel particularly noted that a study on the effects of Detoxamin® in pediatric patients may offer an edge in gaining approval of ABR’s new drug product, as the FDA may currently be encouraging companies to provide health solutions for pediatric use.

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