REGULATORY

FDA Considering Self-Collection Sample Regulation

The U.S. Food and Drug Administration (FDA) may be considering selfcollection of samples for cervical cancer screening. The agency is seeking guidance on the evaluation of cervical sample … [Read more...]

REGULATORY

FDA Medical Device User Fees Rise as Part of Reauthorization

On Oct. 1, the new 2018 U.S. Food and Drug Administration (FDA) user fees go into effect. Diagnostics manufacturers will notice increased medical device user fees, including a doubling of 510(k) … [Read more...]

DISTINGUISHED SERVICE

Kellison Award goes to FDA’s Dr. Alberto Gutierrez

Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after more than 25 years of public service from his post as … [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...]

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...]

EMERGING TESTS

Testing Recommendations Expand as Zika Season Approaches

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

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 Reclassifies Rapid Flu Antigen Tests

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...]


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