BIO International Convention - Legal/Intellectual Property
The FDA's enforcement authorities span the entire life cycle of biotech products, from research to press releases on new product developments to marketing activities, and the consequences of a failure to ensure compliance and respond effectively to FDA can ruin companies and careers. Commissioner Hamburg recently announced a significant change in the way FDA handles warning letters, and the agency is also changing its areas of enforcement focus, with a particular emphasis on liability for company executives. Everyone involved in developing and marketing FDA-regulated products should be aware of the changing landscape of FDA's investigational and enforcement authorities with respect to both companies and executives. Everyone should be prepared to handle inspections and investigations, have appropriate policies in place, and understand how to respond effectively to enforcement actions.