Stephen Ostroff’s picture

By: 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.

Russ King’s picture

By: 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 the FDA.

By: Ken Miller

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).

By: Schaeffer Smith

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 physician alignment and integration required to achieve these goals.

Jim Bevier’s picture

By: Jim Bevier

A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day, and you never know how many people are going to show up at the door. Let’s look at two concepts that help clarify the concept of takt time and how best to apply it.

ASQ’s picture


Strengthening communication between caregivers and patients should be a top priority for reducing healthcare costs and improving patient experience, according to a new poll of U.S. healthcare quality improvement professionals conducted by ASQ, the world’s largest network of quality resources and experts.

Jon Speer’s picture

By: Jon Speer

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The problem, however, is that too often people forget to ask themselves “Why?”

Syndicate content