Resources

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million […]

FDA is the only federal agency that touches the lives ofeveryAmericanseveraltimeseveryday. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. Instead, FDA Matters provides its third annual “State of the FDA.” As reflected in last week’s column, I think that FDA did well […]

Just like great football coaches watch film of opposing teams, we have to watch what the FDA is doing – learn their tendencies and habits. One of the best ways to do that is through our film – the FDA 483. Need a quick refresh? Here’s a great list of 20 web-based (mostly free) resources […]

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 […]