Building Compliance in India
This Spring I was invited to an International Informatics summit in Hyderabad, India with the aim of discussing global harmonization as a means to a
June 14, 2011
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This Spring I was invited to an International Informatics summit in Hyderabad, India with the aim of discussing global harmonization as a means to a
The FDA has taken several more steps toward a 21st century regulatory framework overseeing personalized medicine. In April, FDA’s Elizabeth Mansfield confirmed the imminent publication of
The journal BioSocieties has published a study critical of the cost estimates of new drug development used by PhRMA and Tufts CSDD. The article notes
Over the next two months, I’ll be giving six public seminars – not including my speech at the NIH – on various aspects of complying
In February, SmarterCompliance newsletter published a detailed six page analysis of FDA’s action plan to revise the 510(k) medical device submission, approval, and post-marketing processes.
Following the FDA announcement to work on pharmaceutical regulatory science with the NIH early last year, the European Medicines Agency (EMA) has announced its partnership
FDAzilla has put together a great list of the top 40 websites (and tweets) in the world on the FDA. Happily, high on the list
If the FDA ever needed another reason to increase its pressure on pharmaceutical and drug firms, it’s this: a November 2010 poll found that the
In the Washington Post, Michelle Andrews has a fascinating piece called “Like a Lollipop at the Dentist’s, but for Grown-Ups” on value-based pricing and insurance
In chapter four, “Larger Landscape Trends,” of my book Get to Market Now!, I analyze the impact of the pre-informed patient, and the challenges drug
Pfizer’s recent pact with UC San Francisco is the latest in big pharma’s move to the new collaborative drug development model that is part of
FDA’s approval of Amgen’s osteoporosis treatment, Prolia (denosumab), came with strings attached. Postmarket surveillance requirements – including Phase IV trials and studies – are increasingly
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