CER Daily Newsfeed

FDA Requests Proposals to Strengthen Real-World Data Methods Supporting Evidence Generation and Regulatory Decisions

(12/23, The Evidence Base) reports “...According to the agency, the regulatory science framework is built around three core ‘charges’ central to the FDA’s mission: Modernizing the development and evaluation of FDA-regulated products; Strengthening post-market surveillance and labeling; Supporting public health preparedness and response. Within this framework, the 2026 priorities highlight two complementary methodological focus areas related to RWD: methods to assess RWD for RWE generation, and methods to assess RWD to support regulatory decision-making. These methods are applied across disease areas, product types, and patient populations as enabling capabilities within the broader regulatory science agenda.” Full

Analyzing US Clinical Guidelines: Evidence and Recommendations

(12/23, Bioengineer.org) reports “...The analysis by Qureshi et al. serves as a call to action for medical communities across the United States. The need for robust research and the incorporation of high-quality evidence in guideline formulation has never been more pressing. By ensuring that clinical practices are firmly rooted in reliable data, the medical profession can contribute to an environment of safety and efficacy that benefits all stakeholders involved—most importantly, the patients.” Full