The Food and Drug Administration (FDA) has had some difficulty over the past two years in
navigating what Commissioner Frank E. Young has described as the" fine line that public …

Setting The FDA is an underfunded agency charged with regulating products that
collectively constitute nearly 25% of the US gross domestic product. 4 A century ago, the …

To remain competitive, drug, device and biotechnology companies must continually pursue
innovative new products and product improvements. Clinical trials, which are essential to the …

OBJECTIVE To review the history of drug regulation by the Food and Drug Administration
(FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid …

Health Options Foreclosed: How the FDA Denies Americans the Benefits of Medical Research
IDEAS home Advanced search Economic literature: papers, articles, software, chapters, books …

This interactive graphic shows major legislative and regulatory events related to approval of
new drugs by the Food and Drug Administration (FDA), drug approvals by year and by …

Generic drugs represent a significant portion of the medical arsenal in treating disease. As
copies of originator drugs, these drugs have been permitted abbreviated approval under the …

Personalized medicine (PM) aims to harness a wave of 'omics' discoveries to facilitate
research and discovery of targeted diagnostics and therapies and increase the efficiency of …

This year, Congress is considering a variety of legislative changes that would substantially
affect the regulation of pharmaceutical drugs. There is growing momentum for congressional …

Abstract The March 23, 2010, enactment of the Patient Protection and Affordable Care Act
(PPACA) and the companion Health Care and Education Affordability Reconciliation Act of …