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
July 26, 2017
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
June 26, 2017
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
May 22, 2017
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
May 17, 2017
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
May 2, 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
23andMe Receives FDA Approval for DTC Genetic Test
April 26, 2017
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
April 26, 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 … [Read more...]
FDA
Reports Indicate Faster FDA Approval Processes
April 26, 2017
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
April 18, 2017
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...]
