Drug Development: Step by Step

Botanical Drug Approval

How do you develop an FDA-approved drug?

  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 supporting the safety and potential for efficacy specific to your product.
  4. Phase 1 Clinical Trials (Is it Safe?): The purpose of this phase is to ensure safety before the product is permitted to advance to large-scale studies. Many botanically based products are able to utilize existing scientific evidence documenting human exposure to the product and known toxicological data in place of conducting these studies. With sufficient documentation, botanical drugs begin the active research process with phase 2 studies.
  5. Phase 2 Clinical Trials (Does it Work?): This is the first step, after an approved IND, for most botanical products. These are often 2-group studies with 20-80 participants per group. They can be completed in 6-8 months each. Late phase 2 studies require more participants than early stage 2 studies. When sufficient evidence exists to support a product's efficacy, a meeting with the FDA is scheduled to advance to phase 3 trials.
  6. Phase 3 Clinical Trials: These are large-scale studies designed to identify the rare, long-term side effects and adverse events that may occur. These studies also identify the optimal dose of a product and confirm its safety and efficacy in a more diverse population. In essence, this stage is a transition phase away from discovery and towards wide-scale human use. The purpose of these studies is to obtain accurate information required to complete the final NDA and the required drug labeling. These studies require more participants and take longer to conduct. However, fewer total studies are required. These may be multi-arm studies with upwards of 1,000 participants.
  7. NDA Submission: This is when the New Drug Application is formally submitted to the FDA. Applications can take 8-12 months to be reviewed.
  8. Drug Approval: If the evidence in the application substantiates the claims, approval is granted and the drug's label is developed according to the evidence compiled in the NDA.
  9. Phase 4 Clinical Trials: Post-Marketing surveillance is required of all drugs on the market.

Most botanical products begin with an IND application and are able to submit evidence of extensive human experience with the product in place of completing steps 2 and 4.

Results that make a difference

Some CROs provide simple cookie-cutter packages with general statistical reports. Our complete packages are developed with your end goal in mind, providing you user-friendly reports, submission ready documentation, and management of regulatory processes, where applicable.

Our team even compiles a research overview in lay terms for delivery to your entire team. Your sales department will love this user-friendly approach.

Meet Dr Hawkins

Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.

She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.