ArticleTherapeutic innovation & regulatory science2025
The Beginning of a "Regulatory Renaissance": Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Following the largest reorganization in its history, the U.S. Food and Drug Administration (FDA) is now working to modernize how it defines and engages in regulatory oversight of the quality of products that the agency regulates. However, the volume and complexity of these tasks, coupled with the size and interdependent nature of the global supply chains that generate and distribute these products, raise questions about how the agency can keep up with the pace of change. This dilemma, together with the FDA's recent reorganization, create an opportunity to rethink the FDA's strategy for regulatory coverage and usher in a "regulatory renaissance." In this article, we examine how the agency is working to develop a more quantitative, comprehensive approach to ensuring that the wide arrays of FDA-regulated commodities are produced and distributed in systems that meet societal expectations for safety and quality in a global digital environment. We discuss a number of tools and methods that the agency can bring to bear to achieve this goal, including leveraging internal FDA data and information from third-party audits; utilizing information from foreign regulators; incorporating data and findings from state and local inspections; and applying sophisticated data technologies including AI systems. The underlying concept for this regulatory renaissance is for the agency to focus on leveraging multiple sources of data, information, and analysis to inform its actions in order to optimize the quality of products produced by regulated industries, including the dimensions of safety, effectiveness, and reliability of manufacturing, as well as distribution and instructions for use throughout their product lifecycle. The degree of success of this approach will depend upon a broad recognition of similar opportunities across the regulated industries, sister federal and state agencies, and academia working on regulatory science.
Indexed as
Identifiers
40069512What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.