What is a Letter of Intent to Regulatory Agencies?

A letter of intent (LOI) to regulatory agencies is a formal document that expresses a pharmaceutical company’s intention to seek regulatory approval or guidance for a specific product, service, or activity (i.e., request a meeting with the agency). It outlines the pharmaceutical organization’s plans, goals, and commitment to maintaining compliance with the regulations of that country.

Why is a Letter of Intent needed?

The LOI serves as a communication tool between the pharmaceutical company and regulatory agencies, providing them a formal channel to communicate their intentions and seek guidance or approval. It clarifies the company’s intentions regarding regulatory matters such as seeking approval for a new drug or pharmaceutical product or requesting for guidance on compliance with existing regulations.

The LOI also can be the first step of a regulatory review process which prompts regulatory agencies to assess what the pharmaceutical organization’s plan is and determine the appropriate or relevant regulatory pathway. If a pharmaceutical company submits an LOI, it demonstrates that it is committed to complying with regulatory requirements and working collaboratively with regulatory authorities. The letter also helps ensure that the company’s activities align with the regulatory standards and requirements, thereby reducing any chances of non-compliance which may hinder the product approval timelines or lead to regulatory penalties.

What is an example of a Letter of Intent?

An example of a situation for a LOI is the US FDA requiring a LOI to be submitted by patient organizations who wish to conduct an externally-led meeting for the “Patient-Focused Drug Development” (PFDD). In this, the LOI shall communicate the following:

• The importance of the meeting in the context of the disease area

• Important details regarding the meeting plan

The PFDD LOI should be able to provide information on the following aspects:

1. Proposed disease area and how it fits with the FDA criteria outlined in the PDUFA V PFDD meeting identification process

2. Proposed goals & objectives of the meeting

3. The target population that is characterized by the range in disease or patient characteristics.

4. The proposed date, time, and location for the meeting.

5. A draft outline of key topic areas, questions, and agenda.

6. Discussions on any other supporting ways to collect patient input.

7. Patient outreach engagement plan.

8. Proposed work products of the meeting.

9. Identify any other relevant collaborators if needed, including their role.

10. Identify specific FDA staff that should also be present in the meeting.

11. Statement of acknowledgement that the US FDA CDER PFDD Staff shall be the primary contact for the externally-led PFD meeting.