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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…
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 CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on…
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…
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 Harvested from Evaporation Could Power Much of U.S., Says Study” Renewal sources of energy like solar…
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?
There tends to be a lack of clarity out…
Ann Cleland
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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, security advisory from the company.
The Industrial Control System Cyber…
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 consumers with a broader selection of foods that can improve peoples’ diets and products that can expand…
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 and medicine would not have been an option for me at that time.
Yet, it is precisely those students…
Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling Steps”
These stairs actually help you go up.
“The Curious Case of the Fidget Cube”
How a product…
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By…
InfinityQS
On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as…
AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).
Responding to the Center for Devices and Radiological Health’s (CDRH’s…
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it assesses a…
Ryan E. Day
Sponsored Content
Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
Rob Mitchum
People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where they can…
Azadeh Shoaibi
The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data…
Brenda Stodart, Renu Lal
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Jon Speer
If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally…
Suzanne Junod, John Swann
The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American health.
These…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Robert M. Califf, Nina L. Hunter
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers…
