regulatory science

Originally published Oct. 3.

"We need to improve our understanding of the safety and efficacy of pharmacotherapy as it applies to individual patients and patient subsets," the agency states in a report released this week.

Leaders from the two government bodies will partner to help FDA bring its regulations up to speed with technological and scientific advancements.

FDA has included personalized medicine among several research areas to which it plans to apply "the bulk" of its $25 million FY 2011 budget increase designated for regulatory science initiatives.

The US Food and Drug Administration has approved Alnylam's RNAi-based therapy Onpattro, according to Stat News.

Harvard Medical School's Seth Cassel and Cigall Kadoch argue in a Baltimore Sun op-ed that the recent TAILORx trial shows the potential of genomic-based medicine.

Researchers in the UK are working on using gene drives to control malaria-carrying mosquitoes, the Telegraph reports.

In PLOS this week: genetic architecture mediating gene expression, metabolomic patterns in multiple myeloma, and more.