FDA Features

Mike Richman's picture
Mike Richman
One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look: Interview:...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients. “GE’s Lessons Won’t Determine Whether You...
Ryan E. Day's picture
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP...
Mike Richman's picture
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That...
Ryan E. Day's picture
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with...
Matthew M. Lowe's picture
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage...
Andreas Engelhardt's picture
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–...
Grant Ramaley's picture
Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards...
Richard Pazdur's picture
Richard Pazdur
During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These...
Mike Richman's picture
Mike Richman
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will...
Scott Gottlieb's picture
Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug...
Vanessa Burrows's picture
Vanessa Burrows
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods. A cosmetic eyelash and eyebrow dye called Lash...
Matthew M. Lowe's picture
Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-...
Janet Woodcock's picture
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's picture
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's picture
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's picture
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's picture
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...