PMC

The Personalized Medicine Coalition defends the US Food and Drug Administration from criticism on its push to shorten the regulatory review process.

Although people have greater access to personalized drugs and tests than ever before, a survey by GenomeWeb and the PMC shows public awareness isn't improving.  

A new report from the Personalized Medicine Coalition highlights new personalized medicines approvals by the US Food and Drug Administration.

The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.

The law contains provisions that proponents say will advance precision medicine and speed new tests to market, but critics worry if this will come at a cost to public health.

The Genetic Research Privacy Protection Act would ensure that federally funded researchers can't reveal genetic data that can identify study participants.

Since the PMI will take some time and more funds to implement, experts believe legislation is needed to ensure the project has continued support.

NextGxDx estimates more than 60,000 genetic test products would come under FDA oversight, which, if accurate, industry players fear would overburden test developers.

FDA Approved

More than a quarter of new drugs approved by the Food and Drug Administration in 2015 were personalized medicines, the Personalized Medicine Coalition says.

The US Food and Drug Administration has approved four molecularly targeted drugs this month, suggesting that personalized medicine has "turned a corner."

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Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.