A recently published review article gives a great insight into what the FDA are up to

The AAPS (American Association of Pharmaceutical Scientists) Journal published a great article this week: The FDA’s Experience with Emerging Genomics Technologies – Past, Present, and Future. It’s open source, so no need to navigate through paywalls or subscription barriers.

The FDA’s role in trying to figure out how to regulate NGS (and other genomic technologies) hasn’t always been met with a positive reception. It’s great to hear from the administration themselves to get a closer look at the challenges they’re trying to work through and the projects they’ve set up to make it happen.

The review raises some important concerns around reproducibility of results, and areas that need to be addressed to standardise analysis, promote data sharing, and optimise data interpretation. It also serves as a great overview of the FDA’s activities in this space, and gives a good run through of how RNA-seq is being used to help produce better therapies.

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