Resources

The FDA’s approach to enforcing product safety and efficacy is evolving when it comes to CMOs and CROs. FDA is increasingly holding both sponsors and contract organizations responsible for a product’s safety and effectiveness. Whether in clinical trials or in the post-market stage, patient safety is the #1 driver for FDA enforcement. So how do […]

One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA. Negotiations are underway between FDA and industry on PDUFA V reauthorization. […]

Did you know that 5 of the top 7 FDA risk enforcement priorities involve your senior management team? Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, top 7 FDA risk enforcement priorities. Learn six do’s and […]

“Land mine” is a term we use for something buried in your company that will blow up if it is uncovered. In court, even an innocuous phrase in a private email from one of your employees, such as, “This will negatively impact the bottom line,” could be a land mine. In a products liability action, […]

The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. In some areas, however, medical device companies lag behind other sectors of the American economy, in particular, the number of companies that have adopted a social media strategy. The term “social media” […]

Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. (The QA Pharm 4/17/11.) The Johnson & […]

The Internet offers a seemingly unlimited information resource for medical device developers, allowing them to tap into regulatory information and guidance, market reports and consumer opinion, as well as in-depth coverage of the state of the industry as a whole. Unfortunately, the broad reach of the online world also means that not all news sources […]

In March, MDCI touched on the sentiment of several medical device industry players and members of the federal government that the FDA is taking too long to approve new products. This feeling was drawn into focus in a blog post by Rep. Joe Pitts on The Hill’s Congress Blog that asked the Administration to improve […]

Once upon a time, I asked this question of a senior management group at an off-site “strategy” meeting. You know—one of those meetings where a working breakfast was followed by a day of golf, and I was the one doing the working. The question was particularly germane to the purpose of my invitation, because these […]

A new FDA final rule for Medical Device Data Systems (MDDS) went into effect this past month, with the intent of simplifying the regulations surrounding a significant portion of IT equipment and software used during the provision of health services. The key aspect of this new final rule is the reclassification of certain MDDS as […]