ARTICLE | Regulation

The FDA's new clinical vigilance

November 22, 1993 8:00 AM UTC

WASHINGTON - Biotechnology companies and clinical researchers say they will not be burdened by an FDA task force's recommendation for more rigorous clinical trial procedures in an attempt to prevent clinical surprises of the kind that dogged the FIAU disaster.

The task force last week recommended the series of regulations after an Eli Lilly and Co. Phase II trial of the FIAU (fialuridine) nucleoside analog caused a series of serious adverse events, including the deaths of 5 of 15 patients enrolled in the trial. Lilly licensed FIAU from Oclassen Pharmaceuticals Inc. as a treatment of chronic hepatitis B...