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Need Better Regulation for Next Gen Sequencing Tests, AMP Urges the FDA
The Association for Molecular Pathology has provided comments to the FDA, urging increased regulation of next generation sequencing diagnostic tests to ensure consistent and proper performance of the tests.
The Association for Molecular Pathology (AMP), the premier global, nonâ€profit organization serving molecular diagnostic professionals, submitted written comments on March 20 to the FDA in response to the agency’s request for feedback in association with its February 20, 2015 public workshop entitled, “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” In its comments, AMP urged FDA to focus its attention on helping to ensure the performance characteristics of next generation sequencing (NGS) instruments, reagents, and related software. AMP further recommended that FDA partner with private sector organizations and experts to set standards for FDAâ€cleared or approved instruments, test kits, and software.
Link to the complete press release:
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Exploring Pharmaceutical Innovations, Trust, and Access With CVS Health's CMO
July 11th 2024On this episode of Managed Care Cast, we're talking with the chief medical officer of CVS Health about recent pharmaceutical innovations, patient-provider relationships, and strategies to reduce drug costs.
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NCCN Data Find Racial, Socioeconomic Disparities in Quality of Care for Metastatic Pancreatic Cancer
April 9th 2025New data from the National Comprehensive Cancer Network (NCCN) reveal that socially vulnerable and minority patients with metastatic pancreatic cancer are less likely to receive recommended treatments and achieve longer survival.
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