It has been a busy week with a dose of travel thrown in for good measure. The temperature change over the last 10 days has been welcome and remarkable. Some rain fell in biblical quantities. And many in Congress have gone home to see if they can sign on for another few years. That part, I suppose, is up to you. For me, the more interesting part of this autumn is anticipation of the seasonal change and wondering how vibrant the leaf colors will be given the lack of rain we had in late summer. One hopes.
In the meantime, the seasons aren't the only thing that's changing. Here is a bit of what happened this week that was kind of interesting – all with a theme of CHANGE:
- FDA Launched Initiative on Advancing Regulatory Science – What does that term mean – regulatory science? To quote FDA, it is "the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products." The agency released a lengthy report on the subject that outlines in two sections – (1) The Promise of Regulatory Science and (2) A Collaborative Implementation Frameork. The document explores seven different public health areas in which advancements in the field of regulatory science can help deliver better products. That sounds kind of dry, but the announcement got a lot of positive commentary and Dr. Margaret Hamburg also talked about it in a speech this week.
- FDA Announces Launch of Facebook Page on Transparency Blog - FDA begins to join the 21st Century launching a Facebook page that has been long anticipated on this blog. FDA has not completed the Social Media Quadrant – (1) a blog, (2) several twitter feeds (3) a YouTube channel, and (4) a Facebook page. And as added good measure, the agency opened a Flickr page. The agency is now fully engaged in activities that many in the industry it regulates thinks is forbidden them…. And the beat goes on.
- NEJM on Reviving the FDA - And speaking of change, the New England Journal of Medicine ran a very nice piece this week about the pace of change at FDA quoting Dr. Joshua Sharfstein as saying "I keep a list of things that I wish were moving faster and a list of things that are moving at just the right speed, and there's nothing on the second list." Good stuff.
- Biosimilars Public Meeting Set by FDA – I posted on this earlier this week, but the importance of the meeting bears repeating. The FDA has set November 2-3 for a meeting to get input on a wide span of questions regarding the development of a regulatory pathway for biosimilars. The scope of the questions is demonstrative of the number of outstanding issues the agency faces and will likely result in a protracted process.
That's it for me folks. Have a good weekend everyone.