FDA Features

Jon Speer's picture
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk. Although risk is a variable we...
Thomas R. Cutler's picture
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint...
Stephen M. Hahn's picture
Stephen M. Hahn
Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing...
Del Williams's picture
Del Williams
Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and...
Leigh Turner's picture
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also...
Stanley Chao's picture
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after...
Quality Digest's picture
Quality Digest
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth. But masks are more than just stitched-...
Grant Ramaley's picture
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in...
Gleb Tsipursky's picture
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a...
Jason Chester's picture
Jason Chester
Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and...
Donald J. Wheeler's picture
Donald J. Wheeler
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to...
Eric Stoop's picture
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in...
Jon Speer's picture
Jon Speer
Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works...
Jon Speer's picture
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens...
Rupa Mahanti's picture
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the...
Sheng Lin-Gibson's picture
Sheng Lin-Gibson
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases...
Randall Goodden's picture
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
What a year. No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX...
Anonymous's picture
Quality Digest
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk...