Weekly Roundup 5-24-13

Yee Hah!  Memorial Day weekend is upon us – and not a moment too soon.  It is time for hectic Spring to ease into lazier days of Summer.  I hope.  As for me, it may seem that I have been lazy of late, but it has been quite the opposite.  It looks like it has been a busy week all around and here is a bit of what happened that I thought was interesting:

Dr. Woodcock Testifies on Drug Compounding – On May 23, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) provided testimony before the House Committee on Energy and Commerce Subcommittee on Health regarding Drug Compounding.  Citing the recent issue that arose related to a fungal meningitis outbreak with a compounded product that has resulted in multiple deaths and illnesses, she provided a historical overview stretching back to 1997 of several other incidents involving compounded products and also discussed additional incidents coming to light this year.  She outlined steps FDA is taking in instituting a risk-based model to identify pharmacies for priority inspections and using investigators who would normally be involved in the inspection of conventional drug manufacturers. She provided interesting details of this experience and noted that the agency is hampered by ambiguities regarding the agency’s enforcement authority in this space.  The testimony has been added to the FDA and Compounding resource tab that has been added to the Eye on FDA blog site.
FDA Approves Marketing of New Diabetes Diagnostic Test – Last week there were a number of “firsts” in the Weekly Roundup and this week we continue in that vein with the announcement by FDA that it was allowing the marketing of the fist A1c test labeled for diagnosing diabetes.  The COBAS INEGRA 800 Tina-quant HbA1cDx assay manufactured by Roche will be available for use by health care professionals.
FDA Activities Related to China - Ever been curious about what FDA does to support the safety of the global supply chain?  This week FDA provided testimony before the Congressional-Executive Commission on China on FDA’s activities related to that country.  Though country-specific, it is also quite educational about the challenges the agency faces and the enormous undertaking the task is in a time of increased globalization.

That’s it for me this week folks.  My thanks to those of you who joined me for the Webinar I held earlier this week.  I hope you all have a wonderful and relaxing long weekend.

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