Abbott
This article was originally published in The Gray Sheet
Executive Summary
FDA review of firm's Feb. 8 response to agency observations at Abbott's Lake County, Illinois facility is expected to be completed in April following an FDA request to extend its review by 45 days. Abbott's response covers both the final audit stipulated in the firm's 1999 consent decree with FDA and the pre-approval inspection by FDA's Center for Biologics Evaluation and Research related to Abbott's Prism assays, company reps note. Abbott is counting on resolution of the consent decree and FDA sign-off on the firm's high-throughput automated blood screening system assays to boost diagnostic sales in 2002 (1"The Gray Sheet" Jan. 21, 2002, p. 9)...