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 January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...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
Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more
Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards. The study...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
On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more
Three and a half years after issuing its draft guidance, on November 22, 2016, the Food and Drug Administration released its final guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance is...more