What do you think about this infographic? Have ideas for future infographics? Post a comment below or email email@example.com. Continue reading
Good question, I’m glad you asked!
It’s true that the FDA releases FDA 483s on their ORA FOIA Reading Room. However, these represent only the most frequently requested 483s. In fact, if you look over the years, there are probably close to 100,000 FDA 483s sitting somewhere on an FDA server. They release only a few a week.
FDAzilla requests many additional FDA 483s from the FDA. Our database is getting close to 5,000 FDA 483s, one of the largest in existence. We then utilize custom software that we have developed over the years to tag each FDA 483 by inspector, inspection, site, inspection date, and other relevant data elements. This tagging enables you to search 483s by any of these data elements in the FDAzilla 483 store.
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
- 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?
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
Over the years, we’ve written quite extensively about avoiding 483s. Here’s a summary of some of the most timeless advice and perspective. Continue reading
Based on our latest data, we’re seeing a major downturn in FDA inspections this year. 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