Year: 2026
Type: article
Abstract: The United States has long set the global standard for pharmaceutical innovation and regulatory rigor.But the global pharmaceutical landscape is more competitive than ever, with other countries designing their regulatory systems and clinical research infrastructure to lure early-stage clinical investment away from the U.S. It is critical to protect clinical research in the U.S. because it ensures that American patients will continue to have earlier access to new therapies and are protected by the world's most advanced regulatory oversight.The Department of Health and Human Services operating divisions, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Advanced Research Projects Agency for Health (ARPA-H), the Office of the Inspector General (OIG), and other relevant HHS components, are committed to maintaining U.S. global leadership in biomedical research and pharmaceutical innovation.This requires coordinated action across all of HHS to eliminate the unnecessary delays, redundant requirements, and regulatory ambiguity that currently slow and disincentivize U.S.-based development, while encouraging the broader biomedical research ecosystem to do the same.This coordinated approach is intended to foster a clinical research economy that delivers timely, safe, and effective medical products to support a healthy America.This roadmap describes a strategic set of initiatives and reforms designed to modernize and accelerate all stages of medical product development, from target and treatment identification, initial planning, through the transition into Phase 2 clinical studies, and beyond.This HHS-wide effort aims to identify and remove unnecessary burden from the path between a promising scientific discovery and the patients who need it, without compromising the privacy, safety or ethical standards that Americans expect and deserve.Many of the initiatives detailed here will initially focus on early-phase research, given the importance of supporting American leadership from the earliest stages of innovation and rapidly emerging evidence of its offshoring.Because HHS both regulates and funds early-stage clinical research and development, the Department plans to use its influence to align expectations, incentives, and standards across the biomedical ecosystem. HHS will advance this mission across several fronts:1.modernizing regulatory requirements and processes 2.improving transparency for regulated entities 3.encouraging the adoption of more efficient practices Executive
Source: Chemical & Engineering News
Author: C&EN editorial team
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: bronze
OpenAlex ID: W7166205717
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