by Tony Chen
The first quarter of 2011 proved to be a busy one for the FDA. We saw a deputy commissioner resign, a chemist charged for insider trading, a couple of big consent decrees, a big cancer drug approval, a big no-news on social media guidance, and more. Here’s our wrap-up of the key developments. Continue reading
It’s a most unfortunate tragedy that the approach taken by many when addressing underlying CGMP compliance issues is effectively based in a checklist mentality—a “To Do List.” To be sure, solving fundamental regulatory compliance problems involves tactical work that is broken down into discrete executable steps. However, I become more convinced every day that the most significant challenges in life—regulatory, or otherwise—are more about “being” than “doing.” Continue reading
by Tony Chen
Yet another consent decree was announced today by the FDA. This time, it is Terumo Cardiovascular Systems, makers of heart machines that circulate blood during heart surgery. Signed by Terumo’s CEO and Vice President of Quality Assurance, the consent decree: Continue reading
By the time a consent decree comes along, it’s no longer a discussion about responses to Form FDA 483s observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time. Continue reading
The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme.
For those of us in the quality assurance and regulatory compliance professions, there has been the curiosity of how the history of manufacturing and compliance woes at Genzyme would factor into the sale price. Continue reading