Resources

Learning from the failures of others is one of the most basic building blocks of scientific discourse, and medical device companies may soon gain access to an important resource from the FDA that could offer substantial insight when it comes to device development. The Administration is considering making public files that describe failed medical devices […]

Having recently flitted about on several of our finest air carriers across several continents, I have thought about how certain practices by the flight attendants are predictably consistent, and others vary. For example, we’re always told to turn off our electronic devices at the point when the airplane doors are closed. However, when it is time to […]

We have previously posted blog articles regarding software applications used as medical devices and how they are affected by FDA regulations, but a new ruling by the FDA has clarified some of the uncertainty surrounding this type of technology. The recently published final rule regarding Medical Device Data Systems (MDDS) addresses several areas of concern […]

It must be that time again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry. So with this edition I offer my opinion not only to those conference planners, but also to my […]

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 […]