Resources

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 […]

Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more attention last week when FDA approved expanded access for adolescents under 17 and HHS Secretary Katherine Sebelius promptly overruled the agency because she found inadequate scientific support for the decision. […]

by Tony Chen Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year. In 2010, the FDA issued 10,437 483s, breaking the previous high-water mark of 9,666 in 2009. Through November 2, 2011, the […]

The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally involved. Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with […]