Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests
Bibliographic Data
| ID | 15807902 |
|---|---|
| Authors | Kushal T Kadakia (0000-0002-9539-7682, Harvard University, corresponding author), James Stirling Ro (0000-0002-9218-3320, Yale New Haven Health System), Joseph S Ross (Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut), Reshma Ramachandran (0000-0003-3845-3606, Yale University) |
| Year | 2025 |
| Volume | 6 |
| Issue | 6 |
| Pages | e252233-e252233 |
| Publication date | 2025-06-20 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | JAMA Health Forum (JOURNAL) |
| Journal identifiers | ISSN: 2689-0186 • E-ISSN: 2689-0186 |
| Publisher | American Medical Association (PUBLISHER • US) |
| DOI | 10.1001/jamahealthforum.2025.2233 |
| PMID | 40540283 |
| OpenAlex | W4411489469 |
| Language | EN |
| Citations received | 1 |
| References cited | 13 |
The case of LDTs illustrates the challenges the FDA faces when adapting regulatory frameworks in response to emerging health technologies. The outcomes of recent reforms and litigation carry substantial public health implications for both diagnostic technologies and the FDA's broader regulatory remit
Business · Environmental health · Food and drug administration · Health care · Political science · Public health · Rulemaking · Biomedical Ethics and Regulation · Ethics in Clinical Research · Law · Medicine
| Citations per year | 1 |
|---|---|
| Citation span | 2026 - 2026 (1) |
| Highly cited | No |