FDA Calls for More Efficient Communications with Sponsors

The FDA is calling on sponsors to make better use of communications during clinical development to help speed up the time to market.

Communication strategies should be drafted early on — around the time of the IND submission — laying out a framework all parties adhere to, the FDA says in newly released draft guidance. This means sharing plans for how often and how both parties would like to communicate, as well as sharing methods for submitting questions and general timelines. More formal strategies are required for breakthrough treatments.

Sponsors can request meetings with the FDA at any time during drug development, but the agency recommends that sponsors request “critical milestone” meetings. Those critical milestones include:

  • Pre-IND meetings for understanding proof of concept and initiating early dialogue;
  • End-of-Phase 1 meetings to review and reach agreement on Phase 2 trial designs;
  • End-of-Phase 2 meetings to plan later studies; and
  • Pre-NDA/BLA meetings to acquaint FDA reviewers with the format and content of a planned application, including labeling and risk management.

Drugmakers can turn to the FDA for advice on toxicology, dosage, trial design, manufacturing, sufficiency of data, regulatory pathways, a drug’s use in pediatric populations and overall product quality and safety seen in studies. The agency notes that it will place a premium on safety issues, and that complex scientific questions will likely need formal meetings, not just back-and-forth discussions.

Almost all requests should be routed through a review division regulatory project manager. The RPM is the primary point of contact for almost all communication, the guidance notes, with some exceptions. FDA officials will attempt to respond to all requests in three days.

The guidance stresses that sponsors should not contact reviewers directly. Some situations might allow sponsors to contact reviewers, but these would be agreed upon by management on a case-by-case basis and should be reported in a memo in the IND file. This would be “an exception to usual best practices, not the norm.”

Several efforts have been made in recent years to streamline communication processes and boost their efficiency, including most recently an FDA guidance aimed at meetings between the FDA and biosimilar makers.

The full guidance is at www.fdanews.com/12-04-15-Development-Communication.pdf. — Victoria Pelham

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