What is a pre IND meeting with FDA?
Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food & Drugs Administration) to demonstrate that your medicinal product is safe, compliant and suitable for testing in humans.
Pharmaceutical companies that are going through the IND application process are allowed to have meetings with the FDA to discuss the development and review of their applications. The meeting is known as the ‘pre IND meeting’ with the FDA. This is an opportunity for the applicant to discuss any scientific, regulatory or safety issues related to the development of a new drug.
The pre IND meeting allows the applicant or sponsor to ask specific questions concerning
- their initial US clinical study (known as the first-in-human (FIH) study for new drugs and biologics)
- the nonclinical program
- manufacturing
- product quality
- regulations
- anything else that is relevant to the IND application
Two types of pre-IND FDA meeting
The FDA offers two programs to aid your IND processes:
- the INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) Program
- the Pre-Investigational New Drug Application (IND) Consultation Program
These programs are designed to make the IND submission and review stages quicker and easier by establishing an effective working relationship between your company and the FDA.
Benefits of a pre IND meeting :
- It is a free service
- It can save an applicant’s time because the FDA can help them to complete the IND application properly, avoid common mistakes, and mitigate the possibility of clinical holds.
- It help build rapport with key contacts at the FDA.
How to request for a meeting
First, applicants need to identify which FDA review division is responsible for reviewing your IND application. The review divisions are organized generally along therapeutic class.
Then, you also need have the following information ready:
- Product name, application number (if applicable), chemical name and structure
- Proposed indication(s) or context of product development
- Type of meeting required (i.e., Type A, Type B, or Type C). And explain why choose the type of meeting.
- A brief statement which details the purpose and objectives of the meeting
- A proposed agenda
- A list of questions grouped by discipline. Alongside each question, provide a supporting statement which outlines its context and purpose.
- Names of all individuals who will attend the meeting, including any consultants. Include their titles and affiliations.
- If possible, provide names of any FDA staff, if appropriate, who should participate in the meeting.
Clarify the purpose and objectives of the pre IND meeting FDA
You should make a brief statement to summarize key results. Do not provide lengthy documentation.
The statement should include:
- Details of any completed or planned studies
- A brief summary of the context and issues
- Relevant data or clinical trials to be discussed
- General overview of critical questions to be explored at the meeting
- How the pre IND meeting fits in to wider development plans
The timelines for pre IND meetings:
After your request for a meeting, the FDA will decide whether or not to schedule a pre IND meeting and decide which format of the meeting. The FDA will typically respond within 21 days and meetings usually take place within 60 days of the request.