The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
In a past blog post, we predicted that data is arguably the products liability issue of the future. Dealing with data is already often a critical part of products liability lawsuits, but with the rise of artificial...more
In the early stages of doing business, emerging businesses often use a distributor to introduce a product to the US market without a full sales force. This requires a solid distribution agreement. As your business expands,...more
Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...more
The often-used phrase of “tone at the top” is inartful in my view – an organization’s leadership culture is defined much more broadly than the word “tone” implies. A company’s culture extends well beyond senior leadership...more
The basics were laid out by Peter Wells and Emiko Terazono in a Financial Times (FT) article entitled “Kobe Steel scandal hits Boeing, Toyota and Nissan”. The Japanese company admitted it had falsified “inspection data on an...more