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...]
EMERGING TESTS
Testing Recommendations Expand as Zika Season Approaches
June 14, 2017
As warm weather sets in across the southern portion of the United States, public health officials are planning for the 2017 Zika season. This mosquito year experts have a better knowledge about the … [Read more...]
PRECISION MEDICINE
FDA Approves First-Ever, Pan-Cancer Drug in Milestone for Personalized Medicine
June 12, 2017
In what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first pan-cancer drug. This is the first-ever approval of a … [Read more...]
FDA
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
May 16, 2017
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...]
FDA
FDA Reclassifies Rapid Flu Antigen Tests
February 14, 2017
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used directly on clinical specimens from … [Read more...]
