Do I need an IND?

Jul 21, 2020

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 product is safe for use on human subjects and is reasonably expected to offer a benefit. This is accomplished through a comprehensive and lengthy application which compiles all of the existing evidence on the ingredients, including laboratory tests, animal testing, manufacturing procedures, and history of human use. The IND also requires a proposed research study so that the FDA can confirm its suitability.

It is a violation of the FDA’s Food, Drug, and Cosmetic Act to ship an unapproved drug in interstate commerce (21 U.S.C. § 355(a)). The IND provides authorization to ship the unapproved new drug to human subjects, participating medical centers, and clinical researchers for clinical research purposes.

Not all nutraceuticals require an IND for...

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Working with FSIHS

Feb 26, 2020

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 having your chief scientific officer, a key representative from your marketing team, and other important officers on this call. This enables us to learn about your target population, the marketing direction for this product, your product’s end user, and the claims you would like to make regarding the finished product. A non-disclosure agreement is typically signed prior to the call.

The call concludes with a proposal for the scientific foundation required to meet your team’s goals. Our expertise in clinical research, the FDA drug authorization process, and FTC claim substantiation allows us to present you with the most efficient and cost effective way to achieve your marketing goals. We will then discuss your budget and timeline for the entire project to ensure...

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FDA Prescription Drug Approval

Feb 06, 2020

Drug Development: Step by Step

  1. Discovery & Development: This is typically the longest phase of the process. During this time, you are identifying active ingredients and developing your formulation.
  2. Pre-Clinical Drug Development: For most chemical prescription drugs, this phase involves laboratory and animal studies to evaluate biological activity, potential safety, and the potential for efficacy. This step is rarely required for botanically based drugs due to the presence of extensive scientific evidence and lengthy human history of exposure to most common ingredients.
  3. IND Compilation & Submission: This is where most botanical products enter the process. During this phase, a detailed application is submitted to the FDA requesting authorization to conduct trials on an investigational new drug. Our team can assist with completion of this application, which requires development of a clinical research protocol and strategy, as well as compilation of existing evidence...
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Reducing Clinical Trial Costs

Jan 24, 2020

Research professionals who understand your bottom line

Clinical trials in the integrative health world are typically seen as luxury expenditures, far exceeding the budgets of most companies in the field. After all, a research team is required to design and conduct clinical trials that adhere to FDA and FTC regulations, provide methodologically-sound results, and demonstrate superiority of your product as compared to a placebo or alternate standard of care.

However, integrative health studies are typically a small fraction of the cost of drug development studies. And our team is experienced at designing and conducting research that not only meets these stringent guidelines but also maintains budgetary goals. One of the ways our team accomplishes this is by noting key areas in which your desired research project could be modified to meet your target budget without compromising quality.

Factors influencing overall study cost:

1. Population of Interest

Who is the end user of...

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A Clinical Trial in Three Steps

Jan 15, 2020

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 of your project. During this step, all of the documents for your study are prepared, reviewed, and submitted, and all of the necessary regulatory authorizations are obtained. Evaluation of an existing IND, preparation and submission of the IRB applications to an accredited ethical review board, registration of clinical trials with a World Health Organization approved registry, and the preparation of any other regulatory documents are all included in this initial fee. These regulatory steps are legally required, but also offer benefits to your study. During this process, regulatory authorities review the study’s overall justification and ethics, the safety of all participants, and overall risks.

Your study’s final protocol is developed and written during this step. The...

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Why Studies Fail

Dec 04, 2019

Not all clinical research investments produce results

When entering into clinical research, the greatest concern is typically whether or not the study will provide evidence that the product works at its intended purpose. But a far greater risk is the study itself failing. Clinical research in integrative health is a fraction of the cost of pharmaceutical research, but it is still a significant investment. When a clinical trial fails, that entire financial investment is lost. There is also a hefty loss of labor and marketing potential.

In today’s integrative health field, close to 80% of clinical trials fail to meet enrollment deadlines and nearly half of all sites enroll either one patient or no patients at all. Even with highly trained statisticians, experienced scientists, and medical advisors, clinical research is unlikely to product results without the oversight of a research team with expertise in conducting human clinical trial research projects. Before investing in a...

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

Nov 22, 2019

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 your end goal is a new structure & function claim, beware that borrowed research is rarely sufficient to meet the FTC’s requirements of substantiation. Your product will need its own clinical trial to substantiate its claim. The good news is that no IND is required and most structure/function claims can be substantiated with only 1-2 phase 2 clinical trials. Because the endpoint is a S/F claim, these studies are typically much faster and more affordable than studies with drug claims as the endpoint.

Drug Claims: To establish your product as an FDA-approved drug, in the absence of existing OTC monographs for your ingredients, you must follow the FDA’s botanical drugs guidance. This outlines the process by which botanical products can become drugs. The first step will be to compile an IND to...

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Science Can't be Borrowed

Nov 08, 2019

Can we use existing studies to support a claim?

With the recent emphasis on clinical research in product formulation, a trend of borrowing research has emerged. Borrowing research refers to the use of existing research to identify the capabilities of an ingredient in natural products. The scientific literature offers a wealth of knowledge about the potential effects your main ingredients may offer your finished products. Many formulators rely on the existing published research to substantiate claims about the product’s effects.

This shortcut is an appealing one, but is insufficient for the task at hand. Existing studies can only identify potential because they differ from studies conducted on your finished product. The gold standard for substantiation comes from human studies conducted on your unique product. While existing studies are useful for identifying potential, they are insufficient to confirm actions within finished products. Borrowing research to substantiate your...

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