Anna Abram’s picture

By: 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 their choices. At the same time, we also face a lot of new challenges. The steps FDA takes to advance these opportunities, and address uncertainties, will directly affect the lives of families.

As part of our commitment to protect and promote the public health, we’re undertaking a comprehensive review of our regulations. Our aim is to ensure that our policies and regulations keep pace with the challenges we face in protecting consumers, and the opportunities we have to improve their lives. As in all our actions, science will remain FDA’s North Star when it comes to our role in devising regulatory policy.

Richard Pazdur’s picture

By: 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 who may not have access to specialized learning opportunities that we need to attract to science, technology, and medicine to continue progress in these fields and ensure the diversity of our scientific workforce.

In particular, oncology and hematology are falling behind other areas of medicine in the adequate representation of racial and ethnic minorities in the physician workforce. Only 2.3 percent of practicing oncologists self-identified as black or African-American, and 5.8 percent self-identified as Hispanic in a 2016 survey by the American Society of Clinical Oncology (ASCO). According to census figures, 13 percent of the U.S. population is black or African-American, and 18 percent is Hispanic.

Dirk Dusharme @ Quality Digest’s picture

By: 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 almost went from a million-dollar success story to a footnote in under a year.

“How Technology Is Disrupting the After-Sales Service Industry”

Two new technologies are helping companies make the most of their after-market service.

AssurX’s picture

By: 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 a class II medical device manufacturer. The FDA laid out several concerns in its April 21, 2017, warning letter, noting areas of CAPA noncompliance.

Among other claims, the CDRH noted that CAPAs opened as far back as 2015 and 2016 did not have adequate corrective actions in compliance with the Title 21 CFR Part 820 Quality System (QS) Regulation.

Scott Gottlieb’s picture

By: 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 taking an efficient, risk-based approach to our regulation, the FDA can promote health through the creation of more new and beneficial medical technologies.

We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop products that can benefit people’s lives.

To this end, the FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers. I will have more to say on many elements of this initiative soon. However, here I want to focus on one critical aspect of this innovation initiative: a new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices.

InfinityQS’s picture

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 Boulder, Colorado; Cook County, Illinois; and Seattle.

Even those across the pond are starting to take notice in the benefits of the tax, and on March 8, 2017, the British government confirmed that it, too, would establish a new sugary-drink tax, known as the Soft Drinks Industry Levy (SDIL). This measure will pass two separate taxes of 18 pence and 24 pence per liter ($0.23 and $0.30 per 33.814 oz) for sugar-added drinks. Other countries that are following suit include Denmark, France, Hungary, Ireland, Mexico, Norway, and South Africa.

AssurX’s picture

By: 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) “Fiscal Year 2017 (FY 2017) Proposed Guidance Development,” the medical device trade group submitted its recommendations for how guidances should be prioritized. In addition to recommending revisions to existing guidances, AdvaMed also suggests which guidances should be withdrawn.

Guidance recommendations ranked

AdvaMed ranked each recommendation with a “high,” “medium,” or “low” priority based on how it affects medical device manufacturer members.

AssurX’s picture

By: 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 medical device manufacturer’s operations and product. The latest initiatives charge regulators and medical device manufacturers to work together more to produce the safest products possible.

Ryan E. Day’s picture

By: 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 quality of life for patients around the world.” For at least one Zimmer Biomet quality engineer, the nature of the company’s products and what it takes to manufacture them takes on a decidedly sensitive tone.

“For us, yes, we make great products, and yes, our company has a good stock price, but when you see a patient walking around with your product in them, it’s pretty compelling,” says Jeff Livingston, senior quality engineer at the Zimmer Biomet complex in Warsaw, Indiana. “I’ve done some pretty cool things in automotive, but what we do here is huge. Mostly it’s about regular folks just trying to live again, trying to get through life without pain.”

GrandparentsWithChild

Rob Mitchum’s picture

By: 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 actually improve patient care.

At University of Chicago Medicine, several collaborations between physicians, researchers, and computational experts have produced such pioneering applications, from the pathology lab to the critical-care wards.

A recent feature in Medicine on the Midway, the UChicago Medicine alumni magazine, offers a tour of these local innovations, spotlighting several Computation Institute (CI) researchers and partnerships along the way. Science Life recently ran the feature as a five-part series, and we’ve broken out the CI contributions to each installment. Read about how agent-based modeling, predictive analytics, high-performance computing, and other computational and data-science efforts are already helping cure disease and improve patient health.

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