In the United States, natural supplements which are made from herbs, essential oils, and other botanical ingredients and are meant to be taken internally are regulated as foods, and are officially classified as dietary supplements. These … Read More
FDA Oversight An Investigational New Drug (IND) application is required before your product can be studied in a clinical trial for a medical outcome. The IND application presents a case to the FDA arguing that your … Read More
Getting Started The first step is to contact us to set up a conference call. This complimentary 60-90 minute call enables our team to learn more about your project and your team’s end goals. We recommend … Read More
FDA Drug Approval. Start to Finish. Step 1: Preparation The first step is to plan your strategy. Do you want to make a structure and function claim or a drug claim? Structure & Function Claims: If … Read More
How do you develop an FDA-approved drug? Discovery & Development: This is typically the longest phase of the process. During this time, you are identifying active ingredients and developing your formulation. Pre-Clinical Drug Development: For most … Read More
Clinical Trials in 3 Steps Step 1: The Start Up Period Immediately after coming to an agreement on a clinical research partnership, the FSIHS Research team begins the Start-Up Period, which is the most labor-intensive step … Read More
The FSIHS Research Center investigates botanical products, dietary ingredients, nutraceuticals, and dietary supplements for safety and efficacy. Our team conducts a wide range of human research studies, including clinical trials.