Research Articles

Insight, tips, and updates on clinical research in the natural products industry

Structure Function Claims

By Dr. Jessie Hawkins | Sep 21, 2020

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

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Investigational New Drug (IND)

By Dr. Jessie Hawkins | Dec 24, 2019

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

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Working with FSIHS

By FHR Research Team | Dec 6, 2019

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

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What does it take to turn a botanical into an FDA-Approved drug?

By FHR Research Team | Nov 24, 2019

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

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Drug Development: Step by Step

By FHR Research Team | Nov 14, 2019

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

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Clinical Trial Process

By FHR Research Team | Nov 11, 2019

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

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