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FDA Amends Its Regulations To Provide For Approval Of Certain New Pharmaceutical Products Based On Animal Efficacy Data
The Food and Drug Administration has amended its new drug and biological product regulations so that certain human drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible. The agency is taking this action because it recognizes the need for adequate medical responses to protect or treat individuals exposed to lethal or permanently disabling toxic substances or organisms.
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Studies Yield Key Insights In Preventing Destruction Of Insulin-Producing Cells
TThe findings of two studies appearing in The New England Journal of Medicine (NEJM) on May 30 bring researchers a step closer to the goals of preventing type 1 diabetes and of preserving insulin production in people newly diagnosed with the disease. The studies, though different in size, goals, design, and outcomes, illustrate the therapeutic potential of an improved understanding of the autoimmune process that leads to type 1 diabetes. more
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New Analysis Confirms Direct Link Between Nurse Staffing And Patient Complications And Deaths In Hospitals
Analysis of data on nurse staffing levels confirms that there is a direct link between the number of registered nurses and the hours they spend with patients and whether patients develop a number of serious complications or die while in the hospital. more
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Intraperitoneal Chemotherapy Shows Promise for Ovarian Cancer
An unresolved question in ovarian cancer therapy is whether injection of post-operative chemotherapy into the peritoneum (lining of the abdomen) is superior to standard intravenous administration. A new study presented Tuesday, May 21, 2002, at the American Society of Clinical Oncology meeting offers additional evidence that intensive intraperitoneal (IP) therapy slows down the disease compared with standard IV therapy. However, IP therapy is also more toxic. more
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Information For Patients: What You Need To Know About Ovarian Cancer
Irregular menstrual periods in young women may be a warning sign of a
hormonal shortage that could lead to osteoporosis, according to a
preliminary study by researchers at the National Institute of Child Health
and Human Development (NICHD). The study, of women with a condition known
as premature ovarian failure, appears in the May issue of Obstetrics and
Gynecology. more
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