FDA releases finalised guidance on best practice for communications between IND sponsors and the FDA

The US Food and Drug Administration (FDA) has finalised guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and the FDA.

The guidance describes the best practices and procedures for timely, transparent, and effective communication at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the public. The guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). This guidance describes:

  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between review teams and IND sponsors
  • The types of advice appropriate for IND sponsors to seek from FDA in pursuing their drug development programs
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between review teams and IND sponsors during drug development
  • Expectations for appropriate methods, including the frequency, of such communications.

This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND.

The guidance describes what to expect in milestone meetings (i.e. pre-IND, end-of-Phase 1 and Phase 2 and pre-NDA/BLA [new drug application/biologics license application] meetings) and how sponsors and FDA work collaboratively during the drug development process.

The following changes were made between the release of the draft and final versions:

  • “Biosimilar biological product development information was expanded and Biosimilar User Fee Act (BsUFA) meeting types were added.
  • Roles and responsibilities for regulatory project managers were clarified.
  • Language describing the formal communication plan for applications in Prescription Drug User Fee Act (PDUFA) program for enhanced review transparency and communication for new molecular entity new drug applications and original biologics license applications and for biologic biosimilar applications reviewed under BsUFA was added.
  • Meeting request parameters were revised in alignment with PDUFA VI.
  • Additional information was added to the Resources for Sponsors and Additional Contacts sections.”

To view the finalised guidance on the best practice for communications between IND sponsors and the FDA during drug development, please click here.