Michael Causey
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues...
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...
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...
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a...
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...
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...
Theresa M. Mullin
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has...
Scott Rader
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-...
Timothy Holbrook
The rising price for the EpiPen, a drug delivery system that is crucial for persons experiencing potentially life-threatening allergic reactions, has resulted in outrage. The price increase, from...
Thinh Nguyen
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination...
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent...
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011...
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use,...
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products...
Rachel E. Sherman
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “...
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in...
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality...
Lawrence Yu
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar...
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from...
Rachel E. Sherman
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and...
