Resources

There is no one answer to the question: what is the state of FDA-industry relations? FDA Mattershears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but […]

How long should it take to review a medical device for public use? The FDA’s current average, 73 days, is too much time, according to the medical device industry. Patient advocacy groups however, claim the current process is rushed and at times negligent. A safer, faster approval process would certainly benefit everyone, but enhancements cost […]

Starting this week, the House will hold hearings on reauthorizing the drug and medical device user fee programs that fund one-fourth of the agency. While user fees have become largely non-controversial, this “must-pass” legislation is Congress’ opportunity to consider dozens of other FDA issues, some controversial and many time-consuming. During the last user fee reauthorization […]

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant. Now, in our unique 90-minute webinar, you can learn the detailed trends of 483 and warning letter for 2012. Our speaker, Dennis Moore, Managing Partner, […]

FDA is the only federal agency that touches the lives of every American several times every day. It’s remarkably broad mandate includes all medical products and 80% of the nation’s food supply, plus countless other products. Despite this, when the President delivers his State of the Union (SOTU) address to Congress this week, it is […]

Before turning to 2012, FDA Matters wanted to take one more look at FDA’s performance in 2011. So much happens at FDA that it’s easy to lose perspective. And no matter what the agency does, somebody will be unhappy. So, should Commissioner Hamburg feel good about the last 12 months? FDA Matters thinks it comes […]

In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use […]

Like anyone else, coming to the end of the year brings a time of reflection and anticipation. I look back and ask the question, “Have I made a difference in anyone’s life?” I look forward and ask, “What do I want to change that I either have control or can influence?” For the pharmaceutical professional, […]

In the FDA-regulated world, success is often defined as approval of a new product or indication based on two, well-controlled clinical trials. However, the scrutiny doesn’t end there. FDA’s mission includes determining whether already-approved drugs perform safely and effectively when used by large numbers of patients in routine medical practice. To understand what happens under […]

It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation. Recently, however, this particular topic isn’t being championed by special interest groups representing medical device companies, but rather by a growing number of concerned outsiders from the venture capital industry who are becoming increasingly convinced that FDA regulations are […]