FDAzilla December update

Hello from snowy Chicago!  This is Tony Chen from FDAzilla with a quick update.

FDA information is often hard to use – to the point of just not using it.  We believe there’s a better way.  So our redesigned website includes free, fully-searchable FDA data, including the FDA employee directory, drugs, device actions, 510Ks, MAUDE, and even a listing of all the 483s in the past 10 years.  The response has been phenomenal, with almost 60,000 pageviews in the last month.  You’ll notice that we’ve started this blog focused on: How can we work smarter with the FDA? As I read some of the submissions from our panel of industry experts, I’m excited to see how much learning can take place among our small fraternity of people who work with the FDA.  And we’re going to (*gasp*) have fun along the way – I can’t wait to have you read these insights as well as some funny front-line stories with FDA inspectors. Here’s our round-up of how the FDA’s been getting tougher.

Speaking of tougher inspections, our research division will be publishing an unprecedented whitepaper: “Avoiding 483s in 2011: Learning from 2010 and anticipating the FDA’s next move” (working title).  It’s based on an analysis of 70+ 483s in pharma and biotech companies in 2010 and interviews with seasoned insiders.  If you want to be alerted when the whitepaper (and the actual 483 reports) goes on sale, just email us.

Keep an eye out also for FDAzilla’s first round of intelligence products to be released in early 2011.  There is so much FDA data that is critical to your business, and that data needs to be more actionable.  Avoiding those all-day meetings, deciding to focus resources strategically, saving real time and real money – this is the goal of the data we provide for you.

Happy holidays, and as always, let us know how we can make your lives around FDA data easier!

Tony Chen
CEO, FDAzilla
tony [at] FDAzilla [dot] com

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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