The Food & Drug Administration (FDA) recently published draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff.” According to the FDA, the guidance is a joint effort by the agency’s drug and biologics centers to describe “timely, transparent, and effective communications” in an effort to bring safe and effective drugs to the public sooner. The draft guidance addresses: 

    • Timely interactive communication with IND sponsors.
    • Scope of appropriate interactions between the review team and the sponsor.
    • Types of advice appropriate for sponsors to seek from the FDA in pursuing their drug development program.
    • Expectations for the timing of the FDA's response to IND sponsor inquiries.
    • Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development.
    The draft guidance follows a request for comment on best communication practices, which was published in October 2014. Comments are due February 8, 2016.

For problems with the site please contact us at