OIVD s Steve Gutman Says FDA Plans to Consider Changing ASR Regulations | GenomeWeb

The FDA is considering changes in its regulations for analyte specific reagents, Steve Gutman, the director of the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety, part of the Center for Devices and Radiological Health, this week.

The FDA’s ASR regulations were written in 1997 and enacted in November 1998 (read the original document here).

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

*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.

In PLOS this week: a sequencing-based screen of Lyme disease-causing pathogen, the range of animals bitten by Anopheles darling mosquitoes in Peru, and more.

An NC State researcher is exploring the use of CRISPR-Cas3 as an anti-microbial, Gizmodo reports.

The Earth BioGenome Project plans to sequence all life on Earth, according to ScienceInsider.

For those who are concerned about Trump administration actions related to science, a new column in Scientific American has suggestions for ways to fight back.