Weekly Roundup 1.31.14

It will be groundhog day this coming week.  I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter.  Dog walks have been painful.  Cars everywhere are covered in salt.  And of course my biggest beef with winter – the days are short and there is no quality time on the front porch.  In fact, there is no time on the front porch.  I am sure many of you will be watching too.  Let’s keep our fingers crossed.

In the meantime, it was a busy week for me and I did not get any postings up, for which I am sorry.  I will endeavor next week to be more fruitful.  Meanwhile, here is a little bit of what I thought I’d pass along from this week:

  • First OPDP Letter of 2014 Posted – The first, and right now only, regulatory action letter from the Office of Prescription Drug Promotion was posted (technically last week, it appears, but only noticed by me this week).  It was for a sales sheet and OPDP’s letter cited several issues with the promotional language.  If you represent a product that is not intended for pregnant women, this is a letter you may want to check out to see how to avoid being dinged by the agency for broadening the patient population indicated in the label.
  • FDA Issues Rule to Prevent Food Safety Risks During Transportation – The seventh and final major proposed rule to be announced under the Food Safety Modernization Act (FSMA) was issued this week by FDA that would require certain shippers, receivers and carriers transporting food by motor or rail to meet specific criteria for sanitary transportation.  An example provided in the press release would be that shippers would inspect a vehicle for cleanliness prior to loading food that is not completely enclosed in a container – for example, fresh produce in vented boxes.  This rule does not cover shippers who have less than $500,000 in annual sales.  Three public meetings are scheduled around the country to discuss the proposed rule and the public comment period runs through May 31.
  • Preparing for Advisory Committee – In case you are interested, I will be presenting next week at the CBI conference – the 5th Annual Effective Preparation for FDA Advisory Committee Meetings on February 6 here in Washington, D.C.  I will be presenting on non-clinical aspects of preparation – so please say hi if you are there.  I will be covering panel intelligence and issues mapping as well as various aspects of pre-approval communications.

That’s it for me after this cold week.  Stay warm and be well and have a good and restful weekend.  Groundhog, do your stuff!

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