FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court’s analysis in Sackett v...read more
FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription...read more
Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, which includes a scientific evidence based process to charac...read more
The Presidential Commission for the Study of Bioethical Issues suggested in its report “Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission...read more
This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA...read more
Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 with the aim of reducing tobacco-related illnesses and deaths by curbing tobacco's appeal to and use by children and ad...read more
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as ...read more
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance...read more
64 Food and Drug Law Journal 717-732 (2009).
Signed into law on June 22, 2009, the Family Smoking Prevention and Tobacco Control Act provides FDA with regulatory authority over virtually every aspe...read more
64 Food and Drug Law Journal, 459-472 (2009).
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now “regulate” very gently, with its ...read more