Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more
The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment. The public, the business community, and government are all currently adjusting to a... Read more
The following 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... Read more
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... Read more
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... Read more
I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder (from his firm's excellent FDALawBlog) surrounding FDA's inspectional authority and whether that authority is "evolving" due to recent Supreme Court decisions. Please... Read more
The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more
The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more
