Article Summary:
The U.S. Food and Drug Administration (FDA) has announced that George Tidmarsh, a Stanford University adjunct professor and biotech industry veteran, will lead its drug center. Tidmarsh has over 30 years of experience in biotechnology, clinical medicine, and regulatory science, and has led the successful clinical development of seven FDA-approved drugs. He has founded or co-founded several biotech companies and has served as CEO and CSO of various pharmaceutical companies.
Tidmarsh’s appointment as the director of the Center for Drug Evaluation and Research (CDER) was announced by FDA Commissioner Marty Makary, who praised Tidmarsh’s scientific, regulatory, and operational expertise. Makary also thanked the outgoing acting CDER director, Jacqueline Corrigan-Curay, for her service.
Tidmarsh has been a vocal supporter of Jay Bhattacharya, the director of the National Institutes of Health (NIH), and has criticized academic research for being “riddled with fraud.” He has also criticized the reporting by Endpoints News about Makary’s reported effort to issue a complete response letter to KalVista for its hereditary angioedema drug.
During an FDA Direct episode, Tidmarsh discussed his plans to improve the FDA’s review process, make it more efficient, and improve communication. He also acknowledged that the agency can be improved and expressed his hope to be a part of that process.