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 a draft FDA guidance on the development and labeling of companion diagnostics. The guidance will … Continue reading →
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 that PhRMA and Tufts claim costs 18 times higher than those analyzed and verified by … Continue reading →
Over the next two months, I’ll be giving six public seminars – not including my speech at the NIH – on various aspects of complying with current 21st century FDA expectations. Here are the core topics… Continue reading at ComplianceZen.com … Continue reading →
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. Subscribers also received… Continue reading at ComplianceZen.com →
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 with MIT. Pharmaceutical regulatory science is a nice code phrase for … Continue reading at … Continue reading →
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 is Cerulean’s own Compliance Zen blog: #8: Compliance Zen – Written by compliance guru John … Continue reading →
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 US public wants the pharma industry to have more regulation than the tobacco industry. You … Continue reading →
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 design pros and cons wherein she discussed how companies are … Continue reading at ComplianceZen.com … Continue reading →
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 and device firms increasingly face in the 21st century. This year, in an October 5th … Continue reading →
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 the 21st century new medicinal product development framework that … Continue reading at ComplianceZen.com →
