ACLA | GenomeWeb


The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs. 

According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.

CMS gave labs an additional year to gear up for the implementation of the Protecting Access to Medicare Act of 2014 and clarified key programmatic definitions.

Since CMS has yet to issue a final rule, legislators are worried that the agency will "improperly rush" implementation to meet the Jan.1, 2017 deadline.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

Legal heavyweights representing the lab industry group explain their arguments for why FDA lacks authority to regulate lab tests.

In an intellectual exercise, Conley plays devil's advocate to the American Clinical Laboratory Association's legal arguments for why FDA doesn't have authority over lab tests.

At the second day of an LDT workshop, industry players told FDA to provide more guidance and details on regulatory areas that the initial draft guidance doesn't touch on.

Although lab industry players have talked of suing the FDA, it hasn't amounted to much more than just talk until this week, when ACLA announced it had retained two prominent lawyers to advise the group on LDT regulatory matters. President Alan Mertz discussed ACLA's legal options in an interview.


In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.