A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?, 70 Food and Drug Law Journal 243–258 (2015)

Posted on July 2015 by Jonathan J. Darrow, S.J.D., J.D., M.B.A. and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier...read more

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The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in...read more

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

Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several year...read more

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to g...read more