Regulatory Guidance Core
Navigating the regulatory landscape of cannabis research
The Regulatory Guidance Core, led by the University of Mississippi (UM), aims to reduce barriers to cannabis research by compiling and interpreting regulatory policies.
The core serves as a clearinghouse for policy guidance, providing up-to-date information on the complex web of cannabis regulations that are subject to change.
The team establishes direct communication with federal agencies like the FDA and DEA to ensure the accuracy of policy interpretations.
The core’s guidance tools help investigators and their research administrators better understand regulatory requirements, which in turn can lead to improved compliance with applications and submissions. By offering a dynamic website and other resources, the core empowers researchers to advance their studies and fosters the development of novel cannabis investigations.
Regulatory Clearinghouse
Purpose: To compile and interpret regulatory policies and serve as a clearinghouse for guidance.
Features:
- Direct communication with federal agencies like the DEA and FDA to provide up-to-date, expert guidance on cannabis regulations.
- Validation of policy interpretations through official correspondence with agencies.
- A repository of general policy guidance available to the public and a restricted area for registered investigators to ask specific questions.
Agency Collaboration
Purpose: To reduce barriers to research by fostering communication and cooperation with regulatory agencies.
Features:
- Monthly online conferences with DEA and FDA to discuss regulations, policy updates, and topics of interest.
- Occasional three-way conferences with multiple agencies when necessary.
- Guidance that can help agencies realize reduced workloads due to fewer erroneous applications and submissions with improved compliance.
Impact and Support
Purpose: To assist researchers and administrators in navigating the regulatory landscape, leading to improved research outcomes.
Features:
- Guidance that enables Institutional Review Boards (IRBs) to conduct informed reviews of clinical study applications.
- Information that can lead to an increase in DEA registrant applications and FDA IND submissions with improved compliance.
- A question-and-answer format on the website for registered investigators to receive timely responses to their policy questions.
Regulatory Guidance Core
Ikhlas Khan, PhD (PI)
Director, The National Center for Natural Products Research
Distinguished Professor
Research Professor of Pharmacognosy
Program Director for FDA Program
***
Dr. Ikhlas Khan is a globally recognized leader in natural products research and the Director of the National Center for Natural Products Research (NCNPR). With a career spanning over three decades and more than 850 research articles to his name, Ikhlas has been instrumental in shaping national standards for botanical safety and quality. His academic leadership includes directing the FDA Center of Excellence and receiving numerous prestigious international awards for his contributions to phytomedicine. Within the R3CR framework, Ikhlas provides critical expertise in the analytical standardization and clinical safety of botanical products, ensuring that cannabis research is supported by rigorous chemical and biological validation.
Mahmoud ElSohly, PhD (PI)
Research Professor for the National Center for Natural Products Research
Professor of Pharmaceutics
***
Dr. Mahmoud ElSohly is a Research Professor at the University of Mississippi and a global authority on cannabis chemistry. Since 1981, he has served as the Director of the NIDA Marijuana Project, bringing over 40 years of experience in isolating cannabis metabolites and advancing forensic drug testing. With more than 350 publications and 50 patents, Mahmoud’s academic leadership has been recognized with lifetime achievement awards from the International Cannabinoid Research Society. At R3CR, he provides unparalleled expertise in the botanical and analytical side of cannabis, ensuring researchers have a rigorous scientific foundation for studying secondary metabolites and product development.
Robert Welch, PharmD
Director of the National Center for Cannabis Research and Education
Research Associate Professor in the Research Institute of Pharmaceutical Sciences
***
Dr. Robert Welch is the Director of the National Center for Cannabis Research and Education at the University of Mississippi. A PharmD graduate of Ole Miss, Robert bridges the gap between clinical pharmacy and the pharmaceutical industry, notably contributing to the clinical trials that led to the first FDA-approved plant-based cannabinoid medication. With extensive experience as a medical science liaison in oncology and epilepsy, he brings a unique clinical perspective to R3CR. Robert focuses on advancing cannabinoid science through healthcare professional education and strategic partnerships, ensuring research translates into meaningful improvements for patient care and medical programs.
Donald Stanford, MS
Assistant Director of the Research Institute of Pharmaceutical Sciences
***
Don Stanford is the Assistant Director of the Research Institute of Pharmaceutical Sciences at the University of Mississippi, where he has spent decades ensuring that cannabis research meets the highest federal standards. With a background in biology and extensive experience in the “Marijuana Project,” Don specializes in the complex logistics of cultivation, manufacturing, and regulatory compliance. At R3CR, he leads efforts to improve research quality and reproducibility. His work is vital in helping investigators navigate the path from botanical raw materials to FDA-compliant clinical data, ultimately helping to bridge the gap between complex plant science and public health safety.