What do you think about this infographic? Have ideas for future infographics? Post a comment below or email firstname.lastname@example.org. Continue reading
Barbara Unger has shared about the new regulatory expectations regarding GMP Regulatory Intelligence. Indeed, we have heard that FDA inspectors have started asking people about what processes they have in place to monitor new regulations, guidelines, and developments. In part, this is why we offer the GMP Regulatory Intelligence newsletter.
Now, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market capital has been lost because of this one issue. The crazy part is this – it’s not even close to being a new issue. As you’ll see, the data integrity story began at least 15 years ago. Continue reading
I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence. It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines. Here’s what she had to say: Continue reading
I hope you read our recent post about the backstory of our company, FDAzilla. We’ve come a long way in 5 years. As we plan for the next 5 years, we’ve been preparing for our annual executive team meeting in April. As such, our team researches and synthesizes the most important trends to which we must respond and adapt. Continue reading
Yesterday was Part I. Today, we get to hear a little more from Barb on her background.
What publicly available information do you depend on for your job? How do you use that information?
I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information quickly. The ICH and PIC/S websites also publish their guidance in an organized way. Compliance actions taken by FDA and EMA are also published. I also read publications in the major newspapers and several blogs. Sometimes the best information can come from an unanticipated source. Continue reading
This week, I got a chance to ask our new editor-in-chief of GMP Regulatory Intelligence a few questions. Her responses were so thorough and insightful that we decided to publish her responses in as a series. Today is part I, where we asked her: “What FDA enforcement trends do you see in your industry?” Continue reading
- Is part of your job to prep your company for FDA inspections?
- Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers?
- Is the FDA ORA reading room bookmarked on your browser?
I find the typical approach to managing massive pharma compliance projects quite fascinating, particularly when it comes to problems that require a fundamental makeover. It reminds me of a three-ring circus. Continue reading
The GMP landscape continues to evolve quickly for drug companies. Now is a good time as any to look back at the last 12 months. Continue reading
Get all the 483s you need. FDAzilla now offers an FDA 483s SUBSCRIPTION SERVICE where you can access all of our 483s any time you want throughout the calendar year. We have one of the most comprehensive libraries of 483s, with 3,500+ 483s that is updated quarterly (We anticipate bringing in at least 1,000 more in the next 12 months).
It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013: Continue reading
The government is still shut down, though the FDA is still about half-open. The question is: which half?
The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading
FDAzilla was mentioned in a front-page story today in the Wall Street Journal. The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.
Current and potential investors of your company may actually be reading your FDA 483.