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Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration and that these minutes accurately reflect what transpired.
The article describes a case in which dysfunctional teamwork was threatening patient care on medical units. Various team-building techniques were used by trained facilitators. Survey results showed that the interventions resulted in improved communication, morale, and working relationships.
Scientifically valid data on the safety of drug use during pregnancy are a significant public health need. Data are rarely available on the fetal effects of in utero exposure in human pregnancies, particularly when a drug is first marketed. Data from animal reproductive toxicology studies, which function as a screen for potential human teratogenicity, are… (More)
PURPOSE To determine which medications are most commonly used by women in the first trimester of pregnancy and identify the critical gaps in information about fetal risk for those medications. METHODS Self-reported first-trimester medication use was assessed among women delivering liveborn infants without birth defects and serving as control mothers in… (More)
BACKGROUND Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients. OBJECTIVE To review product labelling in… (More)
PURPOSE A report of the clinical features, treatment, and outcome of patients who developed hemolytic anemia (HA) temporally associated with fludarabine (Fludara; Berlex Laboratories, Richmond, CA) therapy for chronic lymphocytic leukemia (CLL). PATIENTS AND METHODS Data on 24 patients who developed HA related to fludarabine therapy were collected from… (More)
Shortages of pharmaceutical drugs pose a serious and growing threat to public health. Although the number of drugs in shortage in the United States in any given year is very small, the number of prescription drug shortages in the country nearly tripled between 2005 and 2010. Drug shortages are becoming more severe as well as more frequent. The affected… (More)
Historically females of all ages have been underrepresented in clinical research. Reasons for this exclusion are multifactorial and may possibly have their origins in regulation that forbid the participation of females of childbearing potential in the earliest phase clinical studies that support drug approval. Decades of female underrepresentation in… (More)