Looking for a Few Good Comments – FDA Identifies Needs for Drug Safety-Related Regulatory Science

The Center for Drug Evaluation and Research’s (CDER) Safety Research Interest Group, a subcommittee of Science Prioritization and Review Committee, is asking for organizations that may be conducting research and/or have interest in collaborating with the FDA in the 7 areas of interest identified by the Agency:

  1. Improve access to post-market data sources and explore the feasibility of their use in safety signal analyses
  2. Improve risk assessment and management strategies to reinforce the safe use of drugs
  3. Evaluate the effectiveness of risk communications of drug safety information to healthcare providers and the public
  4. Improve product quality and design, manufacturing processes, and product performance relating to safety
  5. Develop and improve predictive models of safety in humans, including nonclinical Biomarkers
  6. Improve clinical trial statistical analyses for safety, including benefit-risk assessment
  7. Investigate clinical biomarkers of safety, including standards for qualification

If you have an idea or ongoing research in any of these areas, FDA is interested in hearing from you.  See the entire Federal Register notice announcing the request for comments here.