ARTICLE | Regulation

Disagreement on multiple trials

March 22, 1993 8:00 AM UTC

ROCKVILLE, Md. - Members of the FDA's Peripheral and Central Nervous System Drugs advisory panel on Friday debated but did not resolve the need to conduct multiple Phase III trials before approving drugs or biologic compounds.

The committee rejected suggestions that the Chiron Corp.-Berlex Laboratories' trial of Betaseron in multiple sclerosis victims could be considered as two independent trials, one Canadian and one U.S. The trial was conceived as a single, multi-center trial and was conducted by one set of investigators...