Objectives A review of new drug approvals (NDAs) by the US Food and Drug Administration
(FDA) for 2006 to 2015 showed that approximately 20% of new drugs had labeling based on …

Policy Points The US Food and Drug Administration (FDA) has in recent years allowed onto
the market several drugs with limited evidence of safety and effectiveness, provided that …

Recently, administrative agencies around the world have engaged in a grand experiment in
regulating and fostering the development of new technologies: regulatory sandboxes. 1 …

Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive.
For some stakeholders, including patient groups and representatives of regulated industries …

This study examines, classifies and discusses the ethical issues of tissue engineering
published in selected online databases from the year 2015 to 2020. In overview, the …

This Article challenges the view that the US Food and Drug Administration (FDA) has
exclusive jurisdiction over life sciences innovations. Many current and forthcoming life …

Although we often-and rightly-think of the US Food and Drug Administration (FDA) as
regulating important therapies for patients, the agency also can regulate non-therapeutic …

A more than century-old problem continues to plague government at all levels: the
movement of government officials through the so-called" revolving door" between …

Fifteen years ago, DMM was founded on the idea that 'application of fundamental
discoveries from (model) organisms will accelerate our understanding, diagnosis and …

Introduction. A growing literature has developed on identifying outcomes that matter to
patients. This study demonstrates an approach involving patient and regulatory perspectives …