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.

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.

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.

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.

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).

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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.

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.

Azadeh Shoaibi’s picture

By: Azadeh Shoaibi

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data in order to investigate adverse events and determine if there is a connection to a specific vaccine.

Multiple Authors
By: Brenda Stodart, Renu Lal

It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.

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