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.

Mike Richman’s picture

By: Mike Richman

On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap:

Greg Anderson’s picture

By: Greg Anderson

The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as those terms are defined in the healthcare regulatory context.

AssurX’s picture

By: AssurX

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

Jon Speer’s picture

By: 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 someone who is near and dear to you.

Anna Nagurney’s picture

By: Anna Nagurney

When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally important to healthcare and life, and it is very volatile at the moment: the blood supply chain.

Dara Corrigan’s picture

By: 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.

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