Thalidomide protocols and patient materials designed by FDA for studies without commercial sponsors.

Executive Summary

THALIDOMIDE PROTOCOLS AND PATIENT BROCHURES DESIGNED BY FDA for trials without company sponsors, FDA Deputy Commissioner Mary Pendergast told the Dermatologic & Ophthalmic Drugs Advisory Committee which convened to review the teratogenicity and neurotoxicity of thalidomide at a Nov. 7-8 meeting. Within FDA, representatives from five different divisions have "helped design [thalidomide] clinical trials and develop protocols when there is no commercial sponsor," Pendergast reported. The group has worked closely with the AIDS Clinical Trials Group on developing trials.