FUNDING

FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts … [Read more...]

FDA

FDA Reports Progress in Advancing Regulatory Science for Diagnostics

The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]

PRECISION MEDICINE

Genomic Markers May ID Risk of Chemo Side Effects

While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]

PRECISION MEDICINE

Genomics May Predict Cancer Treatment Side Effects

While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]

STAFFING

Survey Finds Soft Skills Sought in Hiring New Pathologists

It is no secret that new graduates may not be fully equipped with the necessary skills for their first job. Even among new pathologists, on-the-job training is necessary to fulfill both the technical … [Read more...]

FUNDING

Trump Budget Proposes Steep NIH Cuts, Hike to FDA User Fees

The headlines are harsh. "Terrible," devastating," and "crippling," are words the biomedical industry is using to describe President Trump's proposed cuts to science and … [Read more...]

PRECISION MEDICINE

Discordant Commercial, Next-Gen Tumor Profiling Results May be Clinically Relevant

Next-generation sequencing is increasingly becoming commonplace to match cancer-associated alterations with targeted treatments. But, a new study raises concerns that marked differences in results … [Read more...]

INVESTMENT

Dx Investments Hold Steady in 2016, Number of Exits Declines

Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]

INVESTMENT

2016 Investments Steady, Exits Decline

Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]

FDA

FDA Watch: New FDA Approvals & Applications in Diagnostics

A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]


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