Weekly Roundup 7.11.14

As we head into the weekend after a busy week, with at least part of the country being informed about significantly cooler temperatures for next week being termed the “poor man’s polar vortex” of the summer – news, if not the name, that is most welcome – here are a few of the things that happened or will happen that are worth noting:

• FDA Holds Webinar on Recent Social Media Guidances -FDA scheduled a Webinar that was held on July 10 for interested parties regarding the publication of the two most recent draft guidances related to industry use of social media.   There was keen interest in the Webinar.  Here is a link to the slides that were presented.   In addition, FDA has created a Web page for industry using social media.  Finally, if you would like to hear more on this topic – and hear about it from a communications perspective – I will be holding a Webinar on July 17 at noon.  It is my intent to review where we are with social media regulation overall – including the two most recent guidances.  I will also raise some implications that became apparent during the agency’s presentation.   You can register for it here.

• Consent Decree with Dietary Supplement Manufacturer – Shedding light on the enforcement process here, FDA this week announced that it had entered into a consent decree with a dietary manufacturer in New York.  The agency issued a Warning Letter regarding violations of current Good Manufacturing Practices (cGMP) in November 2012 that FDA said went unaddressed.  The consent decree terms include the recall and destruction of all dietary supplements manufactured by the company since February 6, 2012 under FDA’s supervision and, of course, to bring manufacturing practices into compliance with cGMP.

• Cellular, Tissues and Gene Therapies Advisory Committee Vacancy – The agency published notice this week that it was seeking nominations for a non-voting industry representative for this important advisory committee.  The agency is also soliciting industry organizations interested in participating in the selection.  This committee reviews information around human cells, tissues, gene transfer therapies and xenotransplantation products, among other things.  The notice has instructions for anyone wishing to nominate or self-nominate.

Optimistically off to find my summer sweaters.  Have a good weekend everyone.