FDA Features

The QA Pharm's picture
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and...
Howard Sklamberg's picture
Howard Sklamberg
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and...
Russ King's picture
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...
Michael Causey's picture
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical...
Michael Causey's picture
Michael Causey
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users. However,...
Anonymous's picture
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...
Eston Martz's picture
Eston Martz
I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement...
Michael Causey's picture
Michael Causey
Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to...
Russ King's picture
Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a...
Patrick Stone's picture
Patrick Stone
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug...
Russ King's picture
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of...
Michael Causey's picture
Michael Causey
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of...
Michael Causey's picture
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget...
Michael Causey's picture
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new...
Michael Causey's picture
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem...
The QA Pharm's picture
The QA Pharm
When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons. 1. Management doesn’t know what is required Executive and...
Michael Causey's picture
Michael Causey
Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on...
Patrick Stone's picture
Patrick Stone
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over. This is troubling. My first question:...
Patrick Stone's picture
Patrick Stone
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles...
Michael Causey's picture
Michael Causey
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (...