Weekly Roundup 12-20-13

Yes, I did it.  Cards addressed and sent.  Gifts purchased, wrapped and sent.  The snow in my snow globe descends quietly and peacefully conveying my own inner serenity….

And here is a little of what happened this week, as 2013 begins to pack its bags:

  • New Food Defense Rule Proposed – FDA is seeking public comment on a proposed rule aimed at bolstering security around the food supply by proposing preventive strategies be put into place through a planning effort by large food facilities.  Under the rule, large facilities would have to examine their operation for possible vulnerabilities and then execute planning to address them.  The Federal Register notice regarding the proposed rule and process for comment can be found here.
  • New Stent Cleared for Marketing to Treat Pseudocysts of the Pancreas – FDA announced this week the clearance for marketing of a new stent that would treat pseudocysts of the pancreas.  The agency said this is the first stent that is specifically designed for this purpose by creating a new and temporary opening from the pancreas to the gastrointestinal tract to treat the condition and provides physicians a new option that offers a less invasive method to treat than surgery to remove the pseudocyst.
  • New COPD Treatment Approved – GSK’s Anoro Ellipta got the approval nod from FDA this week.  It is a combination, long-term treatment that is inhaled. The product label will include a boxed warning and is not indicated for use in patents with asthma.
  • Soap on a Rope – This week the agency put the spotlight on antibacterial soaps by issuing a proposed rule that would require manufacturers of such soaps to prove that their long term use is safe and that the efficacy of such products exceeds use of plain soap and water and products not being able to do so will be re-formulated and relabeled.  This does not affect hand sanitzers or sanitized wipes.  The proposed rule will be available for comment for 180 days.

That’s it for me this week.  For those celebrating a holiday next week, my very best wishes.

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