The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy and quality issues. At the same time, public interest in these innovative therapies more

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is more

This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency’s FOIA more

The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation more

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United more

The statute and regulations administered by the Food and Drug Administration (“FDA”) do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the more

Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Framework, 69 Food and Drug Law Journal, 237-272 (2014)

Posted on April 2014 by Diane E. Hoffmann, Claire M. Fraser, Frank Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few more

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by more

Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. more

Ensuring Medical Device Effectiveness and Safety: A Cross — National Comparison of Approaches to Regulation, 69 Food and Drug Law Journal, 1-24 (2014)

Posted on January 2014 by Daniel B. Kramer, M.D., Yongtian T. Tan, Chiaki Sato, Ph.D., LL.M. and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, more