In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production.
Like it or not, Hollywood shapes perceptions on key societal issues. Jenny McCarthy and Jim Carrey, notably, have been vocal in their questioning of vaccine safety, having a huge influence upon their Hollywood brethren and thus the mainstream public.
Any crime covered by the press inspires a wave of copycats. So, it seems, the global heparin supply chain will have to be closely monitored for some time. Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin.
Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis. And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W.
The prospect of California's e-pedigree and drug serialization legislation being pushed back to 2015 (from 2009, then 2011) has the industry breathing a sigh of relief, or is it a sigh of frustration? Drug Channel's Adam Fein, back from his self-imposed blog-cation, weighs in.
An fyi: Steve Simske of Hewlett-Packard offers a nice, unbiased (though HP-oriented) perspective on current anticounterfeiting measures from his Security Printing and Imaging blog. Definitely worth a view. Today he reminds us of the potential benefits of using stable isotopes as a way of authenticating processes by which APIs and...
The California Board of Pharmacy has shown that it is willing to get tough with pharmacies that may have exacerbated the impact of the heparin crisis. It has fined nearly 100 hospital pharmacies who did not properly adhere to Baxter's heparin recall earlier this year.
The California state assembly has passed SB 1307, a measure that sponsor Sen. Mark-Ridley Thomas says is designed to ensure patient safety, but will in actuality yet again push back the proposed compliance date for drug manufacturers and distributors to meet electronic pedigree requirements to 2015--rather than the 2011 (and...