Expecting something from the FDA is a risky endeavor, and that makes it all the more worthwhile to read the tea leaves every once in a while. The agency will struggle to maintain traction in 2012. Congress began second guessing … Continue reading →
Last week, I served as the keynote quality speaker at the international Personal Care Products Council’s 2011 Science Symposium in Newark, New Jersey. The turnout was very impressive … Continue reading at ComplianceZen.com →
Since FDA announced its intent to vigorously enforce 21 CFR 11, I’ve collected various questions posed by attendees at my workshops and speeches on 21 CFR 11 compliance. Now with a year’s track record of new Part 11-related FDA warning … Continue reading →
Supplier quality management is complicated enough. Yet, too often, we shoot ourselves in the foot, making supplier qualification and oversight more complicated, more removed from business realities than necessary. Speakers and attendees at … Continue reading at ComplianceZen.com →
FDA Commissioner Hamburg has created a new FDA enforcement directorate, the Office of Global Regulatory Operations and Policy, under Deb Autor. The goal is to strengthen FDA oversight and enforcement of global supplier controls … Continue reading at ComplianceZen.com →
The FDA recently awarded Johns Hopkins University a three-year contract to develop advanced analytical strategies to mine the data residing within multiple FDA databases. The goal is to … Continue reading at ComplianceZen.com →
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 competitive edge, especially when it comes to lab informatics. Hosted by … Continue reading at … Continue reading →
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 →
