L K Ball
Affiliation: Food and Drug Administration
- An assessment of thimerosal use in childhood vaccinesL K Ball
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Foodand Drug Administration, Rockville, Maryland 20852, USA
Pediatrics 107:1147-54. 2001..This action was prompted in part by a risk assessment from the Food and Drug Administration that is presented here...
- Evaluating the immune response to combination vaccinesL K Ball
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Food and Drug Administration, Rockville, MD 20852, USA
Clin Infect Dis 33:S299-305. 2001....
- Current status and future trends in vaccine regulation--USAL A Falk
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, FDA HFM 481, 1401 Rockville Pike, Rockville, MD 20852, USA
Vaccine 19:1567-72. 2001..If US licensure is sought, communication with the FDA throughout the clinical development of a product is essential to identify and implement the appropriate strategies for demonstrating the safety and effectiveness of a new product...
- Should the vaccine injury compensation program be expanded to cover adults?M A Lloyd-Puryear
Division of Vaccine Injury Compensation, Bureau of Health Professions, U S Health Resources and Services Administration, Rockville, MD 20857, USA
Public Health Rep 113:236-42. 1998..After considering the staff report, NVAC chose, in 1996, not to advise the Department of Health and Human Services to include adult vaccines in VICP...
- Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting systemR Ball
The Vaers Working Group Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Pediatr Infect Dis J 20:219-23. 2001..We identified six cases of SJS or TEN after vaccination without other obvious triggers, suggesting that SJS and TEN might very rarely be caused by vaccination. Confirmation of this hypothesis will likely require controlled studies...