The daffodils are expressing their buttery flavored confidence; tulips look robust and ready to pop; the garden beds are mulched and the deck newly stained. The barbeque pit is cleaned and pansies reside in all of the flower boxes boasting the multiple colors of a crayon box. Yes, Spring is definitely here.
And here's some of what happened this week:
- FDA To Solicit Input on Bisphenol-A – Next week the FDA will make publicly available 5 documents related to findings on Bisphenol-A and will be soliciting input from the public regarding 4 of them. The announcement states that while publication of these documents is not required, the agency is doing so because of the complexity of the issue as well as the fact that there has been such high public interest in the regulatory approach to Bisphenol-A. It certainly is in better keeping with the new transparency that the agency is seeking to establish as it attempts to restore its brand among consumers and policy-makers.
- FDA to Issue Proposed Rule on Neurological and Physical Medicine Devices – The FDA is going to make some neurological and physical medicine device regulations that would establish special controls and would exempt some of the devices from premarket notification requirements.
- FDA To Require More Pediatric Information from Device Manufacturers – In what is likely to be a continuing trend to increase the regulation over the manufacturing and marketing of devices, the FDA announced this week that it would be requiring manufacturers to include particular information about devices and their use in a pediatric population. The requirement asks for pediatric that is "readily available" – indicating that separate clinical trials are not being required – but indicating in the release about the rule that if the information is not included, the device may not be approved. The FDA has a resource page set up on the topic.
The FDA also added two new videos to their YouTube channel this week. The first explains how the FDA protects public health and the second looks at food safety.
I must admit I’m a little disappointed you did not mention the Pfizer payola disclosures. It was all over the press: (NY Times, Reuters, AP, NY Daily News, Politico, etc.) You must have seen something about this, I’m sure.
I’ve been told by a MD colleage that this is a pretty common practice.
Sorry to disappoint. I actually didnt see it, but I was in Berlin most of the week and actually was playing catchup today. Thanks for the heads up though. Best, M
Does it stand to reason that the FDA will then approved devices for adults but not in the pediatric market. One would think that more clinical trials would be needed then.