I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I prepped the porches for the latest onslaught of snow and ice with shovels and salt.
Soon. Spring is only a few weeks away and this weekend, Daylight Savings is upon us!
In the meantime, here is a bit of what happened this week that caught my eye in case you missed it.
- First Mobile App Launched by FDA – Catching up to the times, FDA announced this week that it was launching the agency’s first mobil app that was designed to speed public access to information about drug shortages. Apparently aimed at health care professionals and pharmacists to give them real time information about drug shortages to support informed medical decision making. Certainly for the many physician offices are turning to pad based technologies to support them in their offices the app should serve a convenient role to expedite information gathering. The app is available for free download via iTunes and the Google Play Store by searching “FDA Drug Shortages” or presumably just “FDA”.
- FDA Spotlights Testosterone Products – The agency issued a drug safety communication this week regarding testosterone products. The agency was cautioning about the use of products for low testosterone due to aging and was requiring a label change to inform of the possibility of increased risk for heart attack and stroke. The agency noted that the products are approved only for low T-levels due to particular medical conditions – not aging. The communication was issued following an advisory committee meeting held on the topic and following a review of studies where some demonstrated a risk and others did not.
- FDA Approves First Biosimilar – I would love to say that I posted my posting yesterday about biosimilars with the knowledge that today was the day there would be a first approval, but that would not be true. Following an advisory committee meeting earlier this year, the agency announced approval today of the first biosimilar drug in the U.S. under the newly established regulatory pathway. The name of the product is Zarxio and it is manufactured by the Novartis company Sandoz and is made with reference to the product Neupogen and will have the same indications which can be reviewed in FDA’s release. The release from Novartis can be found here.
That’s it for me this week folks. Let’s hope this is the last snowy, icy weekend. Don’t forget to Spring Forward Sunday morning at 2 AM.!