General discussion, page-5252

Most opportune timing for Camargo to post this link on twitter concerning Pre-Ind Meetings

A Pre-Investigational New Drug Application (Pre-IND) meeting can be a valuable component in planning a development program.

For companies that have not previously interacted with the FDA in the early stages of a product’s development, a Pre-IND meeting is an opportunity to receive the Agency’s feedback and guidance.

While FDA guidance documents can provide helpful information, they are broadly applicable to several types of products.

Through a Pre-IND meeting, a sponsor can get the Agency’s unique advice for a specific product.

Interacting with the Agency early in a development program can reduce time to market in several ways:
Identifying and avoiding unnecessary studies
Ensuring that necessary studies are designed to provide useful information
Gaining FDA support for a proposed strategy
Minimizing the potential for a clinical hold
Providing an opportunity for the creative exchange of ideas
Obtaining regulatory insight
Minimizing costs
Clearly defining the endpoints and goals of the development program

Given these advantages, it is always advisable to seek the FDA’s guidance early in a drug’s development.
The first step is to prepare a Pre-IND (or PIND) meeting request submission with the questions for the FDA to answer.

Asking the appropriate questions is critical because the FDA uses information in the request letter to determine (a) if a face-to-face or teleconference meeting or written responses should be granted (or denied) and (b) which reviewers will be at the meeting to facilitate a productive discussion.
The key to a successful Pre-IND meeting is getting clarity from FDA reviewers on what development activities are necessary to work toward NDA approval. This clarity allows the sponsor to estimate the cost, duration, and potential risks of the program and is especially important for complex development programs. To gain this understanding, sponsors must ask the right questions in the right way.

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GLAH