Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard ...read more
The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients t...read more
Second Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011.
While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important inform...read more
Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media ...read more
First Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011.
The current system of regulating the multi-billion-dollar pharmaceutical industry via market exclusivity comes from ...read more
Implementation of REMS began in March 2008 and by mid-2011 close to 200 New Molecular Entities (NMEs) and New Drug Applications (NDAs) (i.e., NMEs plus new doses and formulations of drugs) approved...read more
First Prize, Long Paper, H. Thomas Austern Memorial Writing Competition, 2011.
Government-provided exclusivity periods provide pharmaceutical companies with incentives to invest in new drugs....read more
In an ongoing dispute, FDA asserts that autologous cultured stem cells used in treatments for orthopedic conditions are drugs and biological products subject to licensing and good manufacturing pra...read more
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as ...read more
Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills...read more