Big Drugmakers Favor FDA Oversight of IVDMIAs, Reiterate Need for More Clarity

Jun 13, 2007

Premium

At least three large pharmaceutical and biotechnology companies support the US Food and Drug Administration’s plan for regulating predictive laboratory-developed tests, but they also asked the agency to clarify how it would regulate the tests, according to publicly available comments on the draft guidance.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

GenomeWeb Premium gives you:
✔ Full site access
✔ Interest-based email alerts
✔ Access to archives

Never miss another important industry story.

Try GenomeWeb Premium now.

You may already have institutional access!

Check if I qualify.

Already a GenomeWeb or 360Dx Premium member?
Login Now.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.

Breaking News

The Scan

Mysterious Third Group

An artificial intelligence-based analysis suggests a third group of ancient hominins likely interbred with human ancestors, according to Popular Mechanics.

This Week in Science

In Science this week: reduction in bee phylogenetic diversity, and more.

In the Past

The New York Times Magazine looks into paleogenomics and how it is revising what's know about human history, but also possibly ignoring lessons learned by archaeologists.

New Bases, New Drugs

The Economist reports on Synthorx's efforts to use expanded DNA bases they generated to develop a new cancer drug.

Featured White Papers

Type 1 Interferon Gene Expression Analysis: Precision Medicine in Lupus

Potential Pitfalls to Life Science Product Launch

Jan

30

Featured Webinar

A Long-Read vs. Short-Read Platform Comparison: Best NGS Approaches for Microbiome Studies

This webinar will provide a comparison of several next-generation sequencing (NGS) approaches — including short-read 16S, whole-genome sequencing (WGS), and synthetic long-read sequencing technology — for use in microbiome research studies.

Feb

21

Featured Webinar

Case Study: 'Companion Informatics' to Automate Immunotherapy Manufacturing and Treatment

This webinar will provide a first-hand look at how Gradalis, a clinical-stage immunotherapy developer, is using an information management solution from L7 to streamline its research, clinical, and manufacturing operations.

Feb

26

Featured Webinar

A Cellular and Molecular Phenotyping Pipeline for Target Characterization in FFPE Biobank Samples

This webinar will demonstrate how a research team at the Firestone Institute for Respiratory Health at McMaster University developed a cellular and molecular phenotyping pipeline using archived samples of lung tissue derived from patients diagnosed with fibrotic interstitial lung disease.

Main menu