FDA ‘best practices’ guide seeks to speed drug development
The document is designed to facilitate timely communication with the Agency according to spokesman Stephen King who told us “each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences, during the IND phase of drug development.
“Because these communications are often opportunities to share information and provide critical advice it is important that interactions be conducted efficiently and consistently, with clear, concise, and timely communication.”
King cited clinical trial design, dose selection, nonclinical study requirements, manufacturing, and facility issues as common meeting topics.
The FDA is currently seeking comments on its draft guide, which was prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER).
“The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public,” added King.
Specifically, the guide details the scope of potential interactions, types of advice that are appropriate to seek, general expectations for communications timing, and best practices and methods for communications.
While the recommendations are nonbinding, and don’t establish legally enforceable responsibilities, King explained that “review staff may depart from guidance documents only with appropriate justification and supervisory concurrence.”
As the guide was just published, the FDA has yet to receive any comments; however, King does anticipate feedback.
The guide will be finalized 18 months after the comment period closes.
