FDA Features

Grant Ramaley's picture
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the...
Brandon Henning's picture
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—...
Stephen Ostroff's picture
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco...
Stephen Ostroff's picture
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative...
Stephen Ostroff's picture
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...
Robert M. Califf's picture
Robert M. Califf
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient...
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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,...
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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...