Search Results: MCHLine

Annotation: This report provides an overview of how the Food and Drug Administration operates in terms of its communications and describes how the agency communicates the benefits and risks of medical products to health care providers and patients, especially underrepresented populations, including racial subgroups. Topics include communications with the general public, including MedWatch, social media, staff and advisory committees, and external stakeholder meetings; as well as designing communications for populations with limited English proficiency, health literacy, and outreach. Appendices include highlights of the risk communications strategic plan, and the Office of Minority Health web site on Federal Health Information.

Contact: U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Telephone: (888) 463-6332 Fax: (301) 443-3100 Web Site: http://www.fda.gov Available from the website.

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Keywords: Communication, Cultural competency, Federal agencies, Health literacy, Limited English speakers, Public health, Racial factors, U.S. Food and Drug Administration

Annotation: This report addresses the Food and Drug Administration's (FDA's) concern that drug effectiveness and adverse affects can vary among children from different racial and ethnic groups. The report focusing on the following questions: (1) to what extent are children of racial and ethnic minority groups represented in clinical studies for drugs granted exclusive marketing rights, (2) are drugs that are used to treat diseases that disproportionately affect racial and ethnic minority groups being studied for safety and effectiveness in children under the pediatric exclusivity provision, and (3) does the Food and Drug Administration have appropriate management systems to monitor the representation of children of racial and ethnic groups in studies submitted for additional exclusive marketing rights? Statistical information is presented in tables throughout the report. The report includes four appendices that discuss the study's scope and provide additional supplemental information.

Contact: U.S. Government Accountability Office, 441 G Street, N.W., Washington, DC 20548, Telephone: (202) 512-3000 E-mail: [email protected] Web Site: http://www.gao.gov Available from the website. Document Number: GAO-03-950.

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Keywords: Child safety, Children, Drug effects, Food and Drug Administration, Minority groups, Minority health, Racial factors

Annotation: This collection of reprints from the journal, Pediatrics, discusses screw caps for baby food jars, vitamin E in human nutrition, nutritional adequacy of infant formulas, vitamin D, lists of readings on feeding and nutrition for physicians and parents, factors affecting food intake, vitamin D intake and the hypercalcemic syndrome, prepared infant formulas, protection of the infant diet, public health nutrition services for children in the United States, a memorial of Robert R. Williams, vitamin B 6 requirements, compulsory testing of newborns for heredity metabolic disorders, national nutritional survey of preschool children, the absence of vitamin D in nonfat dry milk, nutritional management in hereditary metabolic disease, baby food as special dietary foods, proposed changes in Food and Drug Administration regulations concerning formula products and vitamin - mineral dietary supplements for infants, and the relation between infantile hypercalcemia and vitamin D.

Keywords: Child safety, Food and Drug Administration, Genetic screening, Hyperglycemia, Infant formula, Infant nutrition, Metabolic disorders, Nutrition surveys, Pediatrics, Public health nutrition, United States, Vitamin B 6, Vitamin D, Vitamin E