Weekly Roundup – 4/22/11

Commuting in DC without school and without Congress is dreamy.  Everything is blooming, except things in my yard.  My neighbor’s lilacs are in bloom, mine aren’t.  My neighbor’s wisteria is blooming, mine isn’t.  Some of my neighbors still have daffodils in bloom.  Mine didn’t bloom this year or last.  I am keeping my fingers crossed about the irises.

In the meantime, here is a bit of what happened in our corner this week:

  • FDA Issues Warning on OTC Products and MRSA Claims – The agency issued a slew of warning letters this week – four to be precise – to companies related to claims being made in marketing their sanitizing products.  The reason for the letters stated by FDA was that the agency lacked sufficient evidence demonstrating that these products are safe and effective for these purposes.“MRSA is a serious public health threat. The FDA cannot allow companies to mislead consumers by making unproven prevention claims,”said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research is quoted in the release.
  • FDA Strategic Priorities 2011 – 2015 Posted – In this environment, long-range planning has become more challenging than ever and given the expansive growth of the agency and the increasing demands upon it, it might seem unsustainable to some.  In spite of that, the agency this week released its long-range priorities.  It is a 50-page document and it might be a fun exercise to track progress against these priorities as time progresses.  “Today, it is clear that the FDA’s job is fundamentally different – and far more complex than it was even a few years ago,” Hamburg said. “We will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies, international authorities, academia, non-government organizations, and the private sector.”
  • Upcoming Meetings of Note – The EMA and FDA are holding a two-day workshop on drug-related progressive multifocal leukoencephalopathy (PML) in London on 25-26 July 2011.  Experts and stakeholders interested in attending should send an expression of interest to PML-workshop2011@ema.europa.eu by 30 April 2011.  The workshop is being hosted by the European Medicines Agency and co-chaired with the United States Food and Drug Administration (FDA). Also, next month the FDA will be holding  a workshop entitled Best Practices for the Prevention of Cargo and Warehouse Theft of FDA Regulated Medical Products and Infant Formula.

That’s it for me this week folks.  I hope you have a wonderful, restful and peaceful weekend.


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