In 2009, I wrote that while patient demand for new drugs and devices would increase, the ability of patients and healthcare organizations to pay for
One question I’m often asked at conferences where I speak is, What advice, based on my experiences, do I have for small companies (less than
A new crop of medical devices currently in clinical trials is bringing personalized medicine to a new level: the devices send signals direct to the
Earlier this year, Blue Cross Blue Shield filed a lawsuit against Pfizer in an effort to recover reimbursements for illegally promoted drugs such as Bextra.
Next Wednesday, I’ll be chairing the 2nd Annual Supplier Quality Management Congress in Bethesda, Maryland. The conference will bring together FDA officials, industry experts, quality
A June 2010 report by the HHS Office of Inspector General raises two issues: FDA’s inability to inspect active foreign clinical trial sites, and the
News that GlaxoSmithKline is facing difficulties enrolling enough patients in a clinical trial for its diabetes drug Avandia should come as no surprise to readers
Cerulean’s compliance consulting advice is not for everyone. Here are ten reasons for you to work with someone else: 1. You don’t really want to
One challenge I always had as an executive in a device or pharma firm was figuring out whether I should hire a consultant or not.
At the suggestion of a friend, I pulled this question from my rather informal list of Frequently Asked Questions (FAQs) I Wish Were Asked. Here’s
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