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Actually, 41,129 to be exact. That’s almost 5 inspections per hour for the entire year of 2012. Based on new data that we obtained from the FDA, here are some other interesting statistics: 2 inspections in Bangladesh 1 inspection in Botswana 223 inspections in China  241 inspections in India 1 inspection in Guantanamo Bay 16 […]

FDA inspections.  If you find yourself googling FDA inspector names, if you see your boss’s new Porsche parked in the parking lot with a license plate that says, “Zero 483s” (true story), then part of your job includes preparing your facility to be ready at any second for an FDA inspection. This post is for you.  Here are […]

byTony Chen I believe that FDA 483s are becoming increasingly important in our industry. Now that we’ve been in this particular space for almost 4 years, I’ve noticed some key trends. More interest from hedge funds. That’s right – we are actually getting contacted more and more frequently by hedge funds, investment banks, and others […]

If your job involves preparing for FDA inspections, watch this video and tell us what you think! Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.

For part 1 of this series regarding budget, click here. Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. Yet, FDA Matters believes that FDA will be strongly impacted by the election’s outcomes. Part 1 of “FDA After the Election” concentrated on the agency’s budget situation. […]

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election.FDA Mattersbelieves this is probably good—any intelligentdiscussion of FDA’s future requires a long-term perspective and a mastery of detail and nuance—both of which are in short supply during “sound bite”-oriented politicking. Yet, FDA will […]

The US Government Accountability Office (GAO) has issuedrecommendationsthat the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies. As some medical devices incorporate more complex technologies and wireless components, the GAO warns that these devices […]

I was recently interviewed about orphan drugs for the British website, “pharmaphorum” and thought my readers might be interested. Here is a sample: HB: How has the orphan drug space changed since the introduction of the Orphan Drug Act 1983? SG: There is really no way to compare the situation. When we passed the Act, […]

It’s Friday. 8:30am. You’re looking forward to a long, nice weekend. Then, you get a call from one of your associates. An FDA inspector is waiting in the lobby. She’s unannounced, she’s experienced, she’s eager, and she’s ready to go. Do you know the feeling? That feeling of that pop quiz in your least favorite […]

FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on […]