FDA, University of Rochester announce partnership for new drug products
Dubbed ACTION, goal is to streamline process for pain-relieving drugs
The U.S. Food and Drug Administration today announced a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.
The initiative is aligned with the FDA's recently launched Initiative for the Advancement of Regulatory Science, and is designed to streamline the discovery and development process for new pain-reducing (analgesic) drug products.
This multi-year, multi-phased initiative will address major gaps in scientific information that can slow down analgesic clinical trials and analgesic drug development. Key objectives include:
* Establishing a scientific and administrative infrastructure to support a series of projects;
* Establishing relationships with key expert stakeholders, industry, professional organizations, academia and government agencies;
* Coordinating scientific workshops with key experts in the field of anesthesia and analgesia;
* Conducting in-depth and wide-ranging data analyses of analgesic clinical trial data to determine the effects of specific research designs and analysis methods.
Study results, best practices, and outcomes of the ACTION Initiative will be available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm as they are developed.