FDA in pain relief partnership with Rochester University
ACTION project aims to streamline development of analgesics
The US FDA has formed the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) initiative with Rochester University to streamline the development process for pain-relieving drugs.
The multi-year, multi-phased project is aligned with the FDA's recently launched Initiative for the Advancement of Regulatory Science, and according to the FDA will address ‘major gaps in scientific information that can slow down analgesic clinical trials and analgesic drug development’.
The ACTION project will:
- Establish a scientific and administrative infrastructure to support a series of projects;
- Form relationships with key expert stakeholders, industry, professional organisations, academia and government agencies;
- Co-ordinate scientific workshops with key experts in the field of anaesthesia and analgesia;
- Analyse analgesic clinical trial data to determine the effects of specific research design and analysis methods.
Study results and outcomes of the ACTION initiative will be available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm as they are developed.