Weekly Roundup 4.13.18

For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it appears that we will have our annual late wintery weather, followed by 20 minutes of Spring, followed by a long, hot summer. In any case, as folks returned from Easter vacation, Congress was back in session and when not focused on Facebook, was having hearings on opioids. And FDA, who did not take a break, was busy too.

Here is a bit of what happened this week.

  • FDA Finalizes Two Guidance Documents on Next Generation Sequencing (NGS) Tests – FDA has been charged with enhancing innovation via, among other means, of reduced regulatory burden. This week FDA issued two guidance documents on NGS Test development that the agency said in its release would enhance the ability to deliver targeted treatment. According to the Commissioner, the guidance documents provide a more modern framework for the development and evaluation of such tests. The first guidance allows for developers to rely on a clinical evidence from FDA recognized databases to support claims in relations to efficacy. The second guidance makes recommendations for designing, developing and validating tests for genetic diseases. In…