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GAO

Critical Reports

Senators point to critical GAO reports on FDA as reason to take up the 21st Century Cures Act, Stat News reports.

A Government Accountability Office report finds fault with FDA's post-market safety tracking.

A GAO review finds no evidence of disparities in grant success rates by gender at agencies with sufficient data, but some agencies are not conducting required Title IX compliance reviews.

The Government Accountability Office squelched a rumor that has been circulating about the firing of an agency investigator due to errors in a report on for-profit colleges. Additionally, the agency said it has not "identified any problems" with a report on the DTC genomics industry that was led by the same investigator.

"The promise of genomics in the practice of medicine is great and exciting, but today the use of personal genomic tests is still not ready for prime time," a CDC official said in a video address to doctors and the general public.

A week after being hit with a GAO report that called test results from consumer genetics firms "misleading," the big three DTC companies criticized the agency for using "unscientific" methods in its undercover investigation, but welcomed greater regulatory oversight.

At a congressional hearing on DTC genomics this week, an FDA official acknowledged that the agency had waited too long to regulate this rapidly growing field. The agency said it is considering an "out-of-the-box approach" toward overseeing the consumer genomics industry.

Since the FDA has indicated that most IVDMIAs will have to undergo either 510(k) or premarket approval, the IoM's recommendations will certainly have implications for this subset of devices.

In Nucleic Acids Research this week: nanopore sequencing workflow to detect antibiotic resistance in gut microbes, TSSPlant tool, and more.

Because gene-edited organisms can cross borders, Gizmodo wonders whether there should be an international body to govern their use.

HHS Secretary nominee Tom Price is to go in front of the Senate Committee on Health, Education, Labor and Pensions today, NPR's Morning Edition reports.

Prior to being closed, Theranos' Arizona lab failed an inspection by regulators, according to the Wall Street Journal.