Okay, so it's only April, but summer is just around the corner. Which means you'll need two things before you head off to the beach. One, you're going to need to hit the gym like a madman, and two, you'll need something to read.
I can't help you with the first one, but thanks to my friends at the FDA, I've got just the thing for your reading list. I mean seriously, would you rather read some steamy novel, or another inside-the-White-House-tell-all, or would you like a real page turner - FDA documents! All kidding aside, FDA has put out quite a few interesting documents in the last week that are at least worth a good skim.
Two of the more interesting documents are the final guidances that FDA published on next generation sequencing (NGS). Even if you're not thinking of developing a test or system using the technology, there is some real interesting content in both. For example, in the NGS guidance on developing germ-line tests, FDA goes into great detail on what should be included in any FDA submission for a NGS test. FDA talks about analytical and clinical validation in how-to guide that is frankly valuable to anyone thinking about bringing a test through the agency.
And the agency's guidance on NGS databases gives some great insights into how the FDA is thinking about regulating any multiplex assay system that is looking at thousands of targets in a single test result. There are some ideas in the document that can be leveraged for similar systems that are dealing with rapidly evolving technologies and areas like cancer or infectious diseases.
The final document that's worth a look is FDA's Medical Device Safety Action Plan. Though clearly targeted at patients and the general public, FDA shares some surprisingly transparent thoughts on topics like cybersecurity and overall device safety, and how they are actively looking to partner with industry to improve both. And while many of the ideas and topics presented in the piece are not necessarily new, they do provide a nice strategic roadmap for manufacturers to at least consider as they develop new and innovative technologies.
What is clear from all three documents is that FDA is working to simplify (and somewhat demystify) the regulatory process. And while these documents don't provide a lot of new information to those of us that have been in this business for some time now, they do show at least a public willingness by FDA to make the the pathway less burdensome and more efficient. So grab your umbrella and sunscreen, and settle in for some fast-paced regulatory reading. I guarantee it will be time well spent. I mean, at least your outside, right?