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
Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await F...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
Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard ...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
Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too dif...read more
65 Food and Drug Law Journal, 347-366 (2010).
Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not a...read more
This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's autho...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
65 Food and Drug Law Journal, 317-346 (2010).
No medical intervention comes without risks. Certain risks may be grave, but will only occur in a fractional percentage of cases. When does the disclos...read more