Forget 2014: New Discussion Paper Outlines FDA’s Current Thinking on LDT Regulation

In December, the U.S. Food and Drug Administration ended two years of anticipation or dread, depending on your point of view, by announcing that it would not finalize the guidance on agency oversight … [Read more...]


FDA Puts Final LDT Guidance on Ice—Agency Decides to Wait for Trump Administration

Whether you dreaded it or craved it, you will not be getting it—at least not any time soon. In the wake of the election, the U.S. Food and Drug Administration (FDA) let it be known that it will not … [Read more...]


Liquid Biopsies Get FDA Attention

In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called "liquid … [Read more...]


Congressional Leaders Query FDA and CMS about Theranos

Earlier this summer, ranking members of U.S. House of Representatives Committee on Energy and Commerce requested a briefing from Theranos to inform the committee about Theranos' efforts to comply with … [Read more...]


FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight

Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents in early July, addressing oversight of next generation sequencing-based tests and … [Read more...]


AACC Adds to List of Alternative LDT Oversight Proposals

Another industry trade group has chimed in on the issue of the U.S. Food and Drug Administration (FDA) regarding its intent to regulate laboratory developed tests (LDTs). The American Association of … [Read more...]


Federal Agencies Prepare to Battle Zika Virus in the U.S.

As spring arrives and the threat of Zika virus grows in the U.S., the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are taking action to address the … [Read more...]


FDA’s LDT Oversight Framework Could Impact 60,000+ Tests

The U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) could affect more than 60,000 genetic tests, according to analysis by Tenn.-based IT firm … [Read more...]

FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics

In a series of three recent FDA Voice blog articles, the U.S. Food and Drug Administration (FDA) surveyed its accomplishments in 2015 and detailed its 2016 agenda. The FDA also separately issued its … [Read more...]


FDA Workshop Addresses Security of Medical Devices

By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of … [Read more...]