A Pre-IND meeting is a Type B FDA meeting intended to obtain Agency feedback to guide your first-in-human/Phase 1 clinical strategy and IND submission. It is typically a Sponsor’s first formal meeting with the FDA (the INTERACT meeting is technically the first formal FDA meeting, but meetings are often denied). The purpose of the Pre-IND meeting is to provide an opportunity for the sponsor to ask questions, prior to IND submission, related to pre-clinical and CMC plans as well as the initial clinical study design.
The Pre-IND meeting is more than just a productive exchange of information, it is also an avenue to obtain meaningful FDA agreement or advice on specific areas to address given the proposed plan.
Person or entity who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. Sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
Food and Drug Administration is a U.S. government agency responsible for regulating food, pharmaceuticals, cosmetics, and medical devices
Investigational New Drug Application (IND) - An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.
Chemistry, Manufacturing, and Controls (CMC) - Crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.