Well, you remember last week perhaps in the Weekly Roundup when I lamented the lack of snow and commented on the fact that it can be quite enjoyable when there is a big snowfall that brings the world to a quiet and even secluded stop. Now, a week later, we are braced for the biggest snowstorm in 100 years. I did not realize the power of wishful thinking. Heck, I wanted to win the Powerball too, but that didn’t happen.
But here are a few things that did happen.
- Duchenne AdComm Postponed – Also last week, reference was made to FDA’s rejection of one NDA that was proposed for the treatment of Duchenne Muscular Distrophy and the scheduling of an AdComm to be held today to consider another. Due to the impending blizzard happening in Washington, D.C. In the notice regarding the postponement, FDA did not say when the new advisory committee meeting would be scheduled and that publication of the date would happen in the Federal Register.
- Draft Guidance on Cybersecurity – As noted in the release about the guidance, the security of medical devices from hacking has been an issue of growing interest for some time. With interconnectedness to other systems comes vulnerability. The draft guidance outlines post-market recommendations for medical device manufacturers and provides parameters for when FDA does and does not need advance notification or premarket review as well as other conditions regarding enforcement. The agency has opened a docket for public comment that will be open for 90 days and also this week held a public workshop on the subject.
- Impact of Diabetes on States – The National Conference of State Legislatures this week released a report that overviews the impact that diabetes is having across the nation focusing primarily on financial impact and released as many states begin their budget deliberations. The report also provides a state by state overview of legislative proposals around the nation that include budget and program recommendations.
That’s it for me this week as I prepare to greet the storm. While this week did not afford much time for posting, being trapped inside will and so look for a few more postings from me next week. Until then, be safe and warm.