To determine the extent to which autopsies yield unexpected findings that are relevant to the patient's death and whether cases with a high yield of such findings can be identified selectively, we studied a total of 233 autopsies at a university hospital and at a community hospital. The rates at which autopsies detected major unexpected findings whose premortem diagnosis would probably have improved survival were 11 percent at the university hospital and 12 percent at the community hospital. Major unexpected findings whose premortem diagnosis would not have prolonged survival were found in another 12 and 21 percent of cases, respectively. Pulmonary embolism and fungal infections in immuno-compromised hosts were the most common major unexpected findings. Neither we nor the patients' physicians were able to identify from the clinical data the autopsies likely to have high yields. Furthermore, the physicians' estimates of an autopsy's expected yield were similar for patients evaluated by autopsy and for matched patients who were not. We conclude that the autopsy continues to yield clinically relevant findings at a high level and that it is not currently possible to predict which cases will have high yields. Autopsies are vital to ensure the quality of medical care, and autopsy rates must be increased substantially if this role is to be fully realized.
Introduction: US legislation, supported by strengthened ethical fiameworks and improved lowed. Few trials specifically studied neonates, infants, and toddm. trial design, has pnhced significant increases in the number of pediatric clinical trials. This has global implications. Method: We reviewed all submissions of pediatric data received by the US FDA fiom 2002 to 2007 in response to new FDA pediatric initiatives. Results: Although 54% of the trials were multinational, the US dominated as a trial location. IIe European Union and k t i n America fd-Conclusion: Although most pediatric drug programs arcglobal, the United States remains the dominant location forpediatric trials. This distribution differs for adult trials. The balance may change in the future. E U and FDA rcgulators should continue to discuss coordinated approaches to minimize unnecessary pediatric tials and to optimize trial design, safety, and conduct so that the limited pediatric populations available are enrdled only in ethically implemented, scientifidy important trials.
By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.
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