FDAnews Drug Daily Bulletin


Nov. 2, 2005

The FDA has named Cindy Buhse acting director of its Office of Testing and Research (OTR). She replaces Ajaz Hussain, who left the agency to join Sandoz as vice president and global head for biopharmaceutical development.

Buhse has been the director of OTR's Division of Pharmaceutical Analysis for the past year and half. Prior to that, she served as the division's deputy director since joining the FDA in 2001. Before joining the FDA, Buhse worked in management positions in production, validation and analytical services at Sigma Aldrich.

OTR was established in 1995 to develop new scientific methods and new regulatory testing paradigms to assure the identity, quality, safety and effectiveness of human drug products. The office also sets the direction for drug quality surveillance activities within the Center for Drug Evaluation and Research, and provides scientific support for the development and application of regulatory policy and decisionmaking.