FDA Solicits Industry Input for OND Policy Priorities
Posted 09 August 2019 | By
A Friday US Food and Drug Administration (FDA) notice is soliciting policy suggestions from industry that review staff at FDA’s Office of New Drugs (OND) can implement in the near future.
To hear from industry on “specific, actionable policy suggestions that could be implemented in the near-term,” FDA is soliciting presentations for discussions at a public meeting set via the Federal Register
notice as well as inviting comments on the topics that the notice discusses.
The meeting is set for 7 November, with the goal of soliciting suggestions on readily and broadly applicable policies across various therapeutic areas or diseases. This differs from the input industry can offer for.guidances
on high-policy initiatives, such as to incorporate real-world evidence and the science of patient input into regulatory decision-making.
The focus of the notice is centered on directing the attention to five topics that are of particular interest for the suggestions to aid OND in focusing on policy priorities while the FDA- and Center for Drug Evaluation and Research (CDER)-wide high-policy initiatives are underway.
FDA solicits input about where OND can facilitate additional guidance or scientific discussion in the near future to improve clarity and promote effective drug development “for various clinical areas linked by a shared therapeutic context,” such as drugs that are intended for the treatment of serious, life-threatening rare diseases. Specific suggestions can also be about where OND can undertake guidance or policy development supporting drug development for diseases that are currently unamenable to targeted therapies. Industry can share views on guidance, benefits, drawbacks to extending novel trial designs to additional therapeutic areas and how to promote effective drug development programs when such approaches cause uncertainty-related tension.
The remaining topic of particular interest to the agency relates to FDA guidances that are not disease- or indication-specific. FDA wants to hear from those who may “believe that OND review divisions are implementing these guidances in different ways.” It seeks recommendations for topics where, “This may reflect a need for guidance revision or additional policy development.”
“Consistent with FDA's broader initiatives and modernization efforts, the clinical and scientific leaders of OND are seeking suggestions on where we can provide regulatory clarity to promote innovative and effective drug development across multiple therapeutic areas,” the agency states in the notice
. The move comes amid the modernization of OND
, a FY 2019 priority
, and CDER