All Features
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…
Dirk Dusharme @ Quality Digest
I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off on vacation last week, so I presented the show myself.
On Friday’s show, we covered:
The FDA Mutual Reliance Initiative In order to lower their inspection costs, avoid…
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
AssurX
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management…
Michael Causey
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don’t bet on it.
In the most recent…
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San…
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has worked intensively to explore ways to enhance the patient’s voice in drug development. Recently the FDA…
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
The rising price for the EpiPen, a drug delivery system that is crucial for persons experiencing potentially life-threatening allergic reactions, has resulted in outrage. The price increase, from about $94 for a two-pack of injectable epinephrine to more than $600 in just nine years, has members…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…