Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management.

Background: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to potential adverse drug experiences, culminating in the Vioxx withdrawal, has resulted in the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Organizational boundaries of medical practice: the case of physician ownership of ancillary services.

Physician ownership of in-office ancillary services (IOASs) has come under increasing scrutiny. Advocates of argue that IOASs allow physicians to supervise the quality and coordination of care. Critics have argued that IOASs create financial incentives for physicians to increase ancillary service volume.

Pregnancy at or beyond age 40 years is associated with an increased risk of fetal death and other adverse outcomes.

Objective: The objective of the study was to determine the frequency of fetal death in women 40 years of age or older (AMA).

Study Design: Retrospective study of all singleton pregnancies delivered at our institution between the years 1989 and 2004 was performed. The primary outcome measure was the risk of fetal death at various gestational ages.

Synthesis and biological properties of novel glucocorticoid androstene C-17 furoate esters.

A series of novel corticosteroid derivatives featuring C-17 furoate ester functionality have been synthesised. Profiling in vitro and in vivo has resulted in the identification of a compound with a longer duration of action and a lower oral side effect profile in rodents compared to budesonide.