Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Friday, the FDA issued the Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Final Guidance for Industry. This final guidance describes the agency’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug and biological product development programs. Please review the Guidance Snapshot and listen to the corresponding Guidance Recap Podcast episode with Dr. Dan Rubin, a statistician in CDER’s Office of Biostatistics, for more information about the guidance.
- On Friday, the FDA published the FDA Voices: “How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety,” by Robert M. Califf, M.D., Commissioner of Food and Drugs and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition. The FDA is embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review. We have outlined an enhanced approach to regulating food chemical safety and as part of this approach we envision a new framework to systematically reassess chemicals post-market.
