Weekly Roundup – 9-21-13

Autumn officially arrived, but it seemed as if we have had a preview for the past several days.  Once September began, the light began to take on a completely different effect, particularly at the end of the day.  The mums are all out for sale at the grocer’s and the nurseries and the pet boarding facility is reminding us it is time to make our Christmas travel plans.   And even though summer is done, it seems that the Fall is getting off to a slow start, perhaps in anticipation of the effects of another impending government shutdown.

Here is a little bit of what did happen.

  • FDA and NIH Create Tobacco Centers of Regulatory Science – Both agencies announced this week what was billed as a first-of-the-kind Tobacco Centers of Regulatory Science (TCORS).  The purpose of the center, which uses designated funds from FDA and which is coordinated by NIH, is to bring together investigators from around the country to develop and evaluate tobacco product regulations.  It is also to help young investigators with training. Their fields of expertise include epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications and marketing.
  • FDA Prohibits Manufacture of FDA-Regulated Drugs from Ranbaxy Mohali, India Plant -FDA to introduce them into commerce in the U.S.  The agency said that it was not anticipated that the action would be the cause of any supply disruptions or shortages of drugs in the U.S. as a result.
  • New System for Identifying Medical DevicesA final rule was announced by the agency today that would allow for a unique device identification (UDI) system to be implemented, having the potential to improve the way adverse events related to medical device use is collected, reported and acted upon.  In addition, the new system should serve as a safeguard against counterfeiting.
  • OPDP Watch – A few weeks ago, Eye on FDA carried a notice in the Weekly Roundup that the entire month of August had gone by without the issuance of any regulatory action letters by the Office of Prescription Drug Promotion (OPDP). The date of a last issuance of a letter was July 31. As we enter the final stretch of September, it may be that we have a second month in a row where no letters have been issued.  There is a lag time between the time a letter is issued and it is posted – and we still have a little over a week left, but interesting to watch.

Ending on a personal note, you may have noticed that I haven’t been around of late.  I have been out on bereavement leave, but am happy to be back now.

That’s it for me this week.  I hope you all have a wonderful, relaxing and safe weekend.

Photo credit:  Anne Becker

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