MANUFACTURING SUPPLEMENT CLEARANCE DELAYS AVERAGE 13 MONTHS
This article was originally published in The Tan Sheet
Executive Summary
MANUFACTURING SUPPLEMENT CLEARANCE DELAYS AVERAGE 13 MONTHS for Hoffmann-La Roche, the company reported at a Sept. 9 "Workshop on Manufacturing Site Changes." The problems created by the delays and the lack of consistency and clarity in agency requirements for site and other manufacturing changes under the current regulatory process were underscored by various industry representatives at the two-day workshop, which was cosponsored by the American Association of Pharmaceutical Scientists and FDA.