Regulatory News

Best Practices for IND Sponsor Communications: FDA Finalizes Guidance

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

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.

In addition, the guidance outlines FDA’s philosophy regarding timely communications with IND sponsors, the scope of appropriate interactions between review teams and IND sponsors, what kind of advice sponsors can appropriately seek from FDA (e.g. regulatory, clinical/statistical and product quality information) and what to expect in terms of FDA response times to sponsor inquiries (as described in the user fee agreements).

"During the course of these collaborative interactions, sponsors sometimes pose questions to FDA that they perceive as simple or clarifying questions with the expectation that only minimal time will be needed for an FDA response," the guidance says. "However, what may appear to the sponsor to be simple or clarifying questions may be more complex and necessitate significant review and communication among review team members, including internal meeting(s), before an answer can be provided. For example, questions that involve interpretation of regulations and statutes, or application of existing FDA policy to novel circumstances, are often complex (not simple) and therefore demand significant vetting and response time. Similarly, questions involving combination products usually demand additional time to solicit and consider feedback from multiple FDA centers and offices."

According to the Federal Register notice announcing the final guidance last Friday, 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 PDUFA [Prescription Drug User Fee Act] Program for Enhanced Review Transparency and Communication for NME NDAs [new molecular entity new drug applications] and Original BLAs [biologics license applications] (also known as the Program) and for biologic biosimilar applications reviewed under BsUFA was added.