Spring has started, but not sprung. Not really. In the days since Spring first started a mere 9 days ago, we have had more snow in the Washington, D.C. area than we had all winter. Still, the daffodils have shown up, poking their heads through the white and looking actually somewhat energized by the bouts of snow and cold rain, which is more than I can say for most of us.
In spite of all that, here is a bit of what did happen in FDA-world this week:
- FDA Approves New MS Treatment – The agency announced approval of Tecfidera (dimethyl fumarate) for the treatment of adults with relapsing forms of multiple sclerosis. For those suffering from MS, most experience episodes of worsening function initially followed by recover periods, but which may become incomplete over time which leads to a progressive decline in function.
- An Alert Over Temporary Tattoos – After saying that it had received reports – though not saying how many – of serious and long-lasting reactions to the coloring used to provide temporary tattoos on the skin, FDA’s MedWatch issued a consumer alert about the practice – agency said that the problems being reported included redness, blisters raised red weeping lesions, loss of pigmentation, increased sensitivity to sunlight, and even permanent scarring. The skin is the largest human organ – let’s take care of it!
- Introduction of Safety and Fraud Enforcement for Seafood Act – It is H.R.1012 in the House and introduced by Congressman Markey and it is S.520 in the Senate introduced by Senator Mark Begich. Seeks to improve interagency cooperation on seafood safety and fraud protection. It seeks to define seafood fraud and requires data to be submitted regularly, particularly regarding frozen or farmed seafood; provides standards for refusal of admission of imported seafood and requires a public website to list exporters of seafood to the U.S. and to track violations. The Eye on FDA Proposed Legislation tab located at the top of the blog has been updated.
That’s it for me this week folks. I have a real good surprise for you on Tuesday so be sure you check in with Eye on FDA!
If you are observing Easter, have a good one. If not, have a lovely weekend. Let’s get on with Spring now….