Resources

The Warning Letter to Ningbo Smart Pharmaceutical Company (dated 3/3011) revealed that they had reported conformance to specifications on Certificates of Analysis when in fact—no testing was done. (Among other issues.) In understated language, the FDA informed Ningbo Smart, “It is essential that your firm only report results to customers when you have actually performed […]

One of the most frequent questions MDCI fields from new medical device companies relates to the FDA’s “De Novo” process. In fact, they get so many inquiries about the De Novo process that they put together this post that addresses the history and function of the process and offers some guidance regarding its viability as […]

Earlier this year, MDCI posted a blog entry about the FDA’s plan to increase the number of employees “on the ground” in regions around the world known to be hotbeds for medical device manufacturing. This personnel decision was driven by the goal to improve the frequency of foreign facility inspections. By expanding its inspection team through the […]

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, […]