Pre-IND and IND Application Submission Procedures for NINDS Grantees

Overview

Submission of an Investigational New Drug (IND) application represents the culmination of the preclinical research and development process and the beginning of the clinical research stage of a drug development program. A typical IND submission is divided into several sections providing appropriate scientific and regulatory information. Principal Investigators (PIs) will be guided in the preparation and submission of pre-IND and IND applications by Regulatory Affairs Consultants funded by NINDS.

While the actual preparation and filing of an IND is a discrete step in the overall discovery and development process, PIs should keep the IND process and requirements in mind while performing preclinical research activities. Importantly, investigators have two important and unique opportunities to work with the Food and Drug Administration (FDA) prior to IND preparation and submission. These opportunities are INTERACT meetings and pre-IND meetings, and each type of meeting represents an opportunity for a dialogue between the researcher and the FDA to ask and answer questions and receive guidance on considerations for work to be performed prior to submitting an IND application.

INTERACT Meetings

An INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER producTs) meeting occurs earlier in the process than pre-IND meetings and allows a sponsor to obtain informal, preliminary feedback on issues related to CMC (chemistry, manufacturing, and controls), preclinical studies, and clinical studies for innovative investigational products that are still relatively early in the development phase.

INTERACT meeting requests may be denied by the FDA due to inappropriate timing of the meeting request (either too early or too late in the discovery and development process). As such, it is imperative to keep in mind that INTERACT meeting requests should be submitted AFTER the collection of proof-of-concept data (in vivo and in vitro) pertaining to the investigation of efficacy and safety, but BEFORE conducting pivotal preclinical safety studies.

Pre-IND Meetings

The purpose of a pre-IND meeting is to discuss important details about the design pre-clinical studies (especially IND-enabling toxicology studies), and to discuss product manufacturing and quality control measures needed to conduct human studies. A pre-IND meeting request is submitted later in the preclinical development process, namely after initial toxicology studies have been performed, but prior to IND-enabling studies.

Investigational New Drug (IND) Applications

An IND application is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biologic product to humans. An IND must be authorized prior to interstate shipment and administration of a new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.

Resources

Further information about INTERACT meetings can be found by visiting:
OTP INTERACT Meetings webpage.

Further information about the pre-IND application can be found by visiting:
FDA Responses and Meetings for Investigational New Drug Applications webpage.

Detailed information about the IND application process can be found by visiting:
What is an IND? webpage.

Detailed information about documentation to be submitted with an IND application can be found by visiting:
Initial IND Application webpage.