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.