July 28, 2016
The following FDA live review inspection information was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management is a “headliner” on the agendas of industry trade association meetings. And […]
December 31, 2015
Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang. As many of us industry insiders have known for some time, FDA has been planning changes to their regulation and enforcement of dietary supplements. On 21 December 2015, the US Food and Drug Administration announced their new […]
December 14, 2015
Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get to reflect on the past 12 months, and think about what the next year will bring. Also though, it’s when the annual FDLI Enforcement, Litigation and Compliance Conference is held […]
November 16, 2015
FDAnews Inspections Summit I recently had the opportunity to moderate a panel discussion on pharmaceutical quality metrics at the 10th Annual FDAnews Inspections Summit in Bethesda, Maryland. The panel included leading experts involved with the FDA and industry initiatives currently underway with pharmaceutical quality metrics. Panel Members The panel members included: The objectives of the […]
October 6, 2015
It is an axiom of marketing that a company’s brand identity is fundamental to long-term business success. It is also well-known that, on occasion, a company’s image needs a refresh – an updated brand image – to ensure it stays relevant in a changing marketplace. Companies as established as Coca-Cola (Coke Experiments with Universal Branding) […]
July 5, 2015
I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder (from his firm’s excellent FDALawBlog) surrounding FDA inspection authority and whether that authority is “evolving” due to recent Supreme Court decisions. Please see the interesting analysis of Mr. Fleder here. LinkedIn Response Mr. Fleder provided a very interesting and […]
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