PPA study
This article was originally published in The Tan Sheet
Executive Summary
Nonprescription Drug Manufacturers Association plans to submit to FDA in mid-March a revised protocol for its case-control study on the potential link between phenylpropanolamine and the risk of hemorrhagic stroke. FDA officials had contacted the study's principal investigator, Ralph Horwitz, Yale University, on Feb. 2 to seek revisions on the PPA protocol. NDMA expects to receive the modified protocol from Horwitz by the end of February. The association had initially hoped to begin the trial in January ("The Tan Sheet" Nov. 1, 1993, p. 9)