CDER

"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.

The centers will hold a public meeting and take comments on its 25-point plan to enhance and streamline its medical devices submission process.

"It's a beautifully constructed bill that has been carefully put together. We hope it might get introduced this year."

Zineh recently answered PGx Reporter's questions about the agency's efforts in pharmacogenomics and personalized medicine.

At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products.

Two FDA officials last week highlighted the agency's ongoing efforts to personalize healthcare by improving internal expertise in pharmacogenetics, increasing its focus on regulatory science, and launching a new group to coordinate its drug and diagnostics divisions’ application reviews for Rx/Dx combination products.

The recommendations cover performance for studies, detection, repeatability, and other practices.

At a March meeting with industry groups, the FDA gathered comments regarding the barriers to drug/diagnostic codevelopment and noted the agency might issue a series of white papers on the topic.

Looking at approximately 326,000 SNPs in 1,053 Swedish subjects, the study is thought to be the first "sufficiently powered" trial to detect genome-wide significance of three SNPs. As a result, study authors note that "additional genes having a major influence on warfarin dose might not exist or be found in the near-term."

A paper appearing in today's issue of NEJM demonstrates that combining genetic and clinical data can improve stable warfarin dose predictions — especially for those taking high or low doses of the drug. Now, large clinical trials in the US and Europe are slated to test the effect such dosing improvements have on clinical outcomes.

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A research duo estimates in PLOS One the number of papers that have used misidentified cell lines.

UK's National Institute for Health and Care Excellence approves GlaxoSmithKline's SCID gene therapy despite cost.

Science reports that Brazilian researchers are petitioning for the reversal of budget cuts.

In PLOS this week: gene flow patterns in common ash, guidelines for using morpholinos in zebrafish, and more.