FDA’s Discouraging Third-Party MDSAP
Third time wasn’t a charm, fourth could be a disaster Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the...
View ArticleBuilding Expertise and Crossing Boundaries to Improve Oversight
Keeping pace with the scientific innovation and global expansion of markets is an FDA priority To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the...
View ArticleCharles Darwin, Social Media, and the FDA’s New Guidance
The FDA’s advice on handling criticism seems a bit obvious If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep...
View ArticleProtecting the Global Drug Supply
Implementing Title VII of the FDASIA Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent...
View ArticleTime to Take a Closer Look at FDA MDDS Moves
Down-classifying medical device data systems may put the public at risk read more
View ArticleEssentials for Sustaining an Operational Pharmaceutical Quality System
The quality management triad After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have...
View ArticleThe FDA Is Reading Your Facebook Page...
...and it doesn’t ‘like’ what it sees read more
View ArticleResponding to FDA 483 Observations, Part 1
Analyzing the inspection results and committing to action This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the...
View ArticleFDA Warning Letter Emphasis
CAPA, CAPA, and more CAPA! After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.read more
View ArticleFinessing an FDA 483, Part 2
Organizing to get the work done Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent...
View ArticleChina Journal: Strengthening Relationships to Protect Public Health
Highlights from an important trip I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the...
View ArticleRegulators Caught in the Act of Protecting Public Health
FDA field inspectors take quality control with them We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at...
View ArticleTop 10 Foregone Christmas Traditions
How many do you remember? Listening to classic Christmas music on a radio station that labeled the songs as “holiday traditions” certainly brought back memories of holiday traditions from the past....
View ArticleHow to Design-In Deming’s Philosophy
The ‘If it ain’t broke, don’t fix it’ era is over In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations....
View ArticleFDA’s CDER Has Ambitious ‘Front-Burner’ Priorities
They may need a bigger burner The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for...
View ArticleA CDRH Priority: Clinical Trials in the United States
Striving to get U.S. patients fast access to safe and effective medical devices At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to...
View ArticleThe FDA’s Action Plan Demands Some Industry Action, Too
It may take years to iron out some wrinkles, but it’ll be worth it The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article,...
View ArticleFour Reasons Companies Come Under a Consent Decree
And a short survey to see where yours stands When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.read more
View ArticleFDA Moves UDI Initiative Further Down the Production Line
The agency gets this one right 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...
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