Perpetual debate regarding the delicate balance between access and innovation and the
protection of the public health and safety dominate discussions of the United States Food …

The Food and Drug Administration (FDA) serves as the primary regulatory gatekeeper for
health products entering the American market. While not always ideal, for most of the …

In late 2016, Congress enacted, and President Obama signed, the 21st Century Cures Act
(“Cures Act”) to promote access to new technology and pharmaceutical products. 1 The …

On December 14, 2006, the Food and Drug Administration (FDA) proposed two new
regulations in the Federal Register amending current regulations governing expanded …

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device
development in the United States. Written in plain English, the concise and jargon-free text …

During fall 1997, legislators, lobbyists, and regulators celebrated a legislative truce in the
decades-old battle over Food and Drug Administration (FDA) reform. With a notable display …

During the 2000 presidential campaign, both candidates supported adding some form of
prescription drug benefit to Medicare. 1 Although the details of the plan con tinue to be …

Over the past few years, the medical device industry has found it increasingly difficult to
convey to policy makers that, as each new law, regulation, or policy has been added to the …

How does one regulate a scientific revolution? Some may answer that regulation is
inherently antithetical to the exploitation of new scientific knowledge-that to regulate the …

Allegations of" coziness" between the US Food and Drug Administration (FDA) and the
pharmaceutical industry tend to accompany times of crisis at the agency. The opposing …