Error message
User error: "arg_0" is an invalid render array key in Drupal\Core\Render\Element::children() (line 97 of core/lib/Drupal/Core/Render/Element.php).All Features
Katherine Watts
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas.
Here’s the first idea: New York Times bestselling author Bruce Feiler…
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation…
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second part of…
Stephen Ostroff
Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.
Tasked with overseeing products that account for about 20 cents of the consumer…
Robert M. Califf, Rachel E. Sherman
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
Michael Causey
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users.
However, the agency isn’t putting the entire onus on medical device manufacturers. The FDA “recognizes that…
Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure that you’re ready for an audit by the Office for Civil Rights (OCR).
I recently wrote that the OCR…
Healthcare reform has undoubtedly created more integrated delivery and payment models based on a culture of quality-focused and cost-efficient clinical management. In one example, many healthcare systems have begun implementing clinical co-management arrangements (“CCMAs”) to accomplish the…
Eston Martz
I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.
Recently I read a great blog post by Tony Taylor, an analytical chemist with a background in…
Taran March @ Quality Digest
As a sort of character-building exercise, I recently opened an unsolicited email from my health insurance provider. I was intent on doing a quick purge of sham, spam, and flimflam, and I figured this one would be no different. But I also know I’m biased against health insurers, so I decided to set…
Michael Causey
Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials Program at the Center for Devices and Radiological…
Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and it just released its new acceptance policy. This new standard, which will be effective…
Patrick Stone
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug Administration (FDA) “officially” list the shortage of drug products as less than 200; however, the pharma…
NIST
A newly released study comparing 34 U.S. healthcare organizations that received the Baldrige National Quality Award with their 153 geographically closest competitors found that the Baldrige Award recipients matched or exceeded their competitors’ measures of healthcare quality and outperformed them…
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. The pump is mostly used in hospitals or other acute…
Michael Causey
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us under the industry’s financial hood.
The GAO, the nonpartisan counting-house arm of the federal…
Michael Causey
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto threat by President Obama.
Not so fast, say opponents who want to eliminate the 2.3-percent excise tax on…
Michael Causey
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of the year tallying up where he had guessed correctly—and where he’d missed the mark. Not many columnists…
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device…
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data are directly related to patient care.
Examples of small data include: • Missed clinic appointments…
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.
If…