Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our...
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….”
That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission...
Malvina Eydelman
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act...
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017,...
Scott Gottlieb
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.
For...
Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going...
Scott Gottlieb
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations...
Lou Valdez
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...
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key...
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the...
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:
“What...
Brandon McFadden
The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results.
For example,...
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...
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”
Ford Motor Co’'s new...
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...
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:
“Energy...
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...
Ann Cleland
If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017,...
Anna Abram
We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing...
Richard Pazdur
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science...
