AGG Partner, Alan G. Minsk, recently wrote an article featured in Regulatory Focus entitled “Hold on Loosely, But Don’t Let Go.” In this article, Mr. Minsk discusses how companies can attempt to contractually delegate to third parties, and it might make sense in many cases. However, it is important to recognize that a company regulated by the US Food and Drug Administration (FDA) remains on the hook to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations. That company also has liability exposure if a problem arises. Mr. Minsk has written the article from a regulatory lawyer’s perspective, identifying issues and listing precautions that companies should consider when evaluating outsourcing opportunities.
To read the entire article, please click here.