Regulation of Laboratory-Developed Tests: The Case for Utilizing Professional Associations
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference4 articles.
Cited by 9 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. National Maintenance Cost for Precision Diagnostics Under the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act of 2020;JCO Oncology Practice;2021-11
2. Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like;The Journal of Molecular Diagnostics;2021-10
3. Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead;Current Opinion in Infectious Diseases;2020-08
4. Global development strategy for companion diagnostics based on the usage and approval history for biomarkers in Japan, the USA and the EU;Personalized Medicine;2014-01
5. Uncertain prognosis for high-quality diagnostics: clinical challenges, economic barriers and needed reforms;Pharmacogenomics;2013-02
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