Multiple Authors
By: Scott Gottlieb, Jeffrey Shuren

In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

Multiple Authors
By: Lou Valdez, Dara Corrigan, Peter Stein

Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products.

Mike Richman’s picture

By: Mike Richman

QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:

The QA Pharm’s picture

By: The QA Pharm

If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.

When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.

The responsibility of quality assurance is to ensure that an effective quality management system (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest


Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.

“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”

Scott Gottlieb’s picture

By: Scott Gottlieb

The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational drugs and devices to patients with serious conditions (generally prior to product approval) when there is no therapeutic alternative.

Mike Richman’s picture

By: Mike Richman

We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:

Jon Speer’s picture

By: Jon Speer

How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?

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