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FDA

The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.

Studies presented at the AACR meeting demonstrated how the registry can be used to evaluate how cancer patients with rare tumor markers respond to treatments.

Norman Sharpless, the current NCI director, is to serve as acting commissioner of the Food and Drug Administration, the New York Times reports.

The budget calls for $34.4 billion for the NIH in the coming fiscal year, including $492 million in resources made available through the 21st Century Cures Act.

Momentum Slow Down?

The Washington Post reports that some health advocates worry that Commissioner Scott Gottlieb's departure from the US Food and Drug Administration will stall certain initiatives.

Healthcare providers continue to worry about the impact of 23andMe's health risk reports but there is also growing acceptance of the DTC testing model.

Scott Gottlieb, the commissioner of the US Food and Drug Administration, has announced he will be stepping down from his post next month.

Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field. 

A Drug or What?

The FDA has yet to determine if fecal microbiome transplants should be treated like a drug or like a blood transfusion, the New York Times reports.

A report from the Personalized Medicine Coalition finds that more than 40 percent of new drugs approved in the US in 2018 were personalized medicines.

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According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.

An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.

US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.

In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.