Resources

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 […]

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 […]

A thousand good deeds of the biotech/pharma industries have been washed away by the decision of K-V Pharmaceuticals to charge $1500 per dose for Makena, a drug that reduces the risk of pre-term delivery in pregnant women. There is an easy comparator: the same therapy has been compounded in pharmacies for years at a cost […]

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: “prohibits the company from manufacturing and distributing two heart-lung bypass systems and […]

On February 14, 2011 the FDA published notice (press release) of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those […]

Hot on the heels of calls from Congress, the President,and prominent medical device industry players to streamline the 510(k) approval process so as to make it easier for innovative treatments to make it to market, comes a new study from the Cleveland Clinic questioning the ability of current FDA safeguards to protect the public from […]

by Tony Chen Due to popular demand, we’ve started a website that’s focused solely on avoiding and responding to 483s. Check it out at FDA483s.com. It’s still in beta phase and the paint is still drying, but I think you’ll get the picture of what this could be – a one-stop shop for resources, presentations, […]

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. This is because the common element […]

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 […]

(Chicago) March 7, 2010 — Though it can cost hundreds of thousands of dollars to respond to a single Form FDA 483, many pharma manufacturers aren’t taking some of the basic steps needed to avoid being cited, according to new research published by FDAzilla, one of the Web’s leading sources on the business of the […]