Rational Therapeutics for Infants and Children Workshop Summary (2000) / Chapter Skim
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1 Introduction
1 Introduction
Pages 8-13
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From page 8... ...
Food and Drug Administration During recent years, the development of rational therapeutics for infants and children has received a great deal of attention from the academic community, the U.S. Congress, industry, and the federal government, particularly the U.S.
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From page 9... ...
In 1994, FDA issued a final rule requiring drug manufacturers to survey existing data and determine whether those data were sufficient to support the presentation of additional pediatric use information in a drug's labeling. The rule explicitly recognized that controlled clinical studies conducted to support pediatric use need not be carried out with a pediatric population if the course of the disease and the effects of the drug are sufficiently similar in children and adults.
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From page 10... ...
The incentive approach was provided by Congress in the Food and Drug Administration Modernization Act of 1997. The legislation includes "Section III," or the pediatric exclusivity provision.
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From page 11... ...
In late 1998, FDA finalized its previously proposed regulations regarding studies in pediatric populations. Although no products found to be safe and effective in adults are to be or have been delayed or denied approval because of a lack of testing in the pediatric population, there is now a requirement for a manufacturer to conduct trials with children in an expeditious manner.
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From page 12... ...
The parent, caretaker, or older child must weigh the benefits of the study to the patient or themselves versus the costs of the loss of work or school and the disruption to the family and daily living that may result from participation in a study. Another critical variable that must be considered for children involves growth and maturation and the expected changes that occur throughout infancy, childhood, and adolescence.
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From page 13... ...
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