The U.S. Food and Drug Administration (FDA) plays a vital role in the process of advancing breakthrough cancer therapies to the public, and the AACR is, therefore, committed to leveraging the vast scientific expertise of the AACR membership to help ensure that the agency can excel in its critical role as a science-based regulatory agency.
The AACR established the Task Force on Regulatory Science and Policy in March 2011 with the goal of supporting the efforts of the FDA to modernize the regulatory process and accommodate the fast pace of innovation in science and technology. The task force will, therefore, lead AACR efforts to work with the FDA to facilitate scientific exchange and provide FDA reviewers an opportunity to hear about relevant scientific advances.
The 2012 Annual Meeting will feature a new track on regulatory science and policy as part of the scientific program. This series will present high quality regulatory science and illuminate the scientific challenges facing regulators. Learn more
Check back: Webcasts of the Regulatory Science and Policy Track will be posted here soon!
FDA Reports & Resources:
The FDA defines regulatory science as “the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.” This webpage describes the agency’s regulatory science-related activities.
This webpage provides information and updates about the Critical Path Initiative (CPI), the FDA's national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated and manufactured.
This report addresses concerns about the medical product development pipeline, one of the most pressing challenges facing the biomedical industries. Release of the report kicked off a new FDA-wide Innovation Initiative, which promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.
This report describes FDA's strategic plan for regulatory science, identifying eight priority areas of regulatory science where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission.
This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA, working with partners, to strengthen the field, both within the agency and throughout the nation.
Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.
This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.
This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment.
Other Reports & Resources:
A partnership between the National Institutes of Health (NIH), FDA and the Defense Advanced Research Projects Agency (DARPA), intended to advance the field of regulatory science.
The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it. The workshop provided an opportunity for stakeholders to clarify and explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, consider its funding needs, and contemplate alternative mechanisms and institutional frameworks for its development and application. This document summarizes the workshop.
In 2010, the IOM’s Forum on Drug Discovery, Development and Translation held a workshop that examined the state of regulatory science and considered approaches to enhance it. As a follow-up to that workshop, the forum held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as discussed in the 2010 workshop.
Each year, this conference brings together experts in cancer drug development from academic and clinical research, industry, federal health and regulatory agencies, and the patient advocacy community to develop consensus-driven solutions to challenges in the development of the next generation of anti-cancer drugs.