FDA

Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation

A trio of recent FDA product approvals in the diagnostics space have belied the agency's traditional reputation for resisting medical innovation. Here's the timeline for what has become an exciting … [Read more...]

NEWS

FDA Approves First NGS Oncology Companion Dx for Multiple Therapies

In May, the U.S. Food and Drug Agency (FDA), the agency known for its stinginess in approving new products, broke new ground by approving Merck's Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor, a … [Read more...]

FDA

FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and criticism over how long the agency takes to issue approvals. And the new … [Read more...]

ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]

FDA

FDA Exempts Certain Class I Devices, Test Kits from 510(k) Filing

The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present … [Read more...]

FDA

FDA Reports Advances in Diagnostics Development

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

23andMe Receives FDA Approval for DTC Genetic Test

23andMe and the U.S. Food and Drug Administration (FDA) recently announced that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]

FDA

FDA Reports “Significant Progress” in Diagnostics Development

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 … [Read more...]

FDA

Reports Indicate Faster FDA Approval Processes

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

Test Kits Included in Class 1 Devices Exempt from 510k Filing

The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks … [Read more...]


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