Weekly Roundup 1/7/11

Happy New Year.

Though it is one of those weeks that is always tinged with a little sadness, isn’t it?  The Christmas trees, once adorned and adored, lie like derelicts along side roads or at the curb in haunting darkness and a reminder that we all grow old.  Christmas bills begin to arrive.  The extra poundage from the culinary indulgences is showing and making us feel not so good about ourselves.  The decorations have to be taken down and relegated to their dark corners until next year (unhanging the stockings….).  Of course, on the bright side, the days grow just a little big longer.

In the meantime, a new Congress has moved in and freshman antics have begun.  And here is a bit of what happened in our world this first week:

  • FDA to require substantial equivalence reviews for new tobacco –  productsIn FDA guidance published this week, the agency outlined a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.  “Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health. “This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. The law requires FDA to carefully examine the impact those products may have on the public health,” said Lawrence R. Deyton, M.S.P.H., M.D., director of the agency’s Center for Tobacco Products. “Products that are equivalent to those which were on the market on February 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health.”
  • FDA launches website to help regulated industries save time and resources –The agency announced this week a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency.  The website includes basic information about the regulatory process, including information that is frequently requested by industry.
  • Repeal of Healthcare Reform Gets Underway – In what can only be described as political theater, the new Congress kicks off its efforts that perhaps signal a continued environment involving more politics than governance with the introduction of legislation to repeal the reform passed by the 111th Congress. There is universal agreement that the effort will ultimately fail, but HHS Secretary Sebelius has been making the case this week for maintaining the law. Still, even if the law holds, it remains to be seen whether or not it will be starved on the vine through mini-repeals and lack of appropriations.  More on that on Monday.
  • Pfizer Canada Shares Social Media Response Chart – Via the charming Natalie Bourne, founder of Marketing 4 Health Inc., who on her blog also called Marketing 4 Health published a set of guidelines devised by Pfizer to provide a response flow chart for social media.  It is very busy indeed, but also interesting and was modified from a chart devised by no other than the U.S. Air Force.

That’s it for me this week.  Have a good weekend everyone and take care.

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2 Responses to Weekly Roundup 1/7/11

  1. Pingback: Tweets that mention Weekly Roundup 1/7/11 | Eye on FDA -- Topsy.com

  2. Nat Bourre says:

    Happy new year Mark. Thanks for including me in your 1st 2011 weekly round-up. I truly appreciate it.

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