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.

AssurX’s picture

By: AssurX

Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

Suzanne Schwartz’s picture

By: Suzanne Schwartz

During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of their medical devices.

Joel Bradbury’s picture

By: Joel Bradbury

Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a talented nurse, she spent months analyzing data to identify what caused the high rate of mortality. She found that hygiene and sanitization were neglected in the triage and care of the soldiers.

Michael Causey’s picture

By: Michael Causey

Brooke Pierce’s picture

By: Brooke Pierce

When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare providers now be more concerned with risk than they have been in years past?

Michael Causey’s picture

By: Michael Causey

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San Jose, California. Shuren’s presentation was one of several sessions of particular interest to life sciences shops.

Kade Moody’s picture

By: Kade Moody

Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false.

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