Readiness assessment
Before embarking on the Pre-IND meeting and IND submission journey, it is essential for a Sponsor (the entity responsible for a drug's development) to conduct a thorough readiness assessment. This assessment is designed to ensure that the data and information to be presented to the FDA at this stage of your drug’s development are complete, accurate, and high quality, which can improve the chances of success for the Pre-IND meeting and IND submission. Please click any of the links in the images below to navigate to the respective sections.
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.
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
