Personnel Changes at the FDA
Dr. Janet Woodcock will be the chief medical officer at the US Food and Drug Administration (Rockville, MD, www.fda.org).
Dr. Janet Woodcock will be the chief medical officer at the US Food and Drug Administration (Rockville, MD, www.fda.org). Dr. Woodcock most recently served as the deputy commissioner for operations. As the chief medical officer she will oversee scientific and planning-related operations for the agency.
John R. Dyer, MPH, will be FDA’s deputy commissioner for operations and the chief operating officer. Dyer will be a part of the senior management of the agency that supports the commissioner in advancing his priority initiatives and will concentrate on strengthening the management, business processes, and information technology of FDA.
Randall Lutter, PhD, will serve as acting deputy commissioner for policy. Lutter will replace Dr. Scott Gottlieb who recently announced his resignation. In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the commissioner on agency policy.
Dr. Shiew-Mei Huang will be the deputy director of the Office of Clinical Pharmacology. Dr. Shiew-Mei has been an FDA senior biomedical research scientist since 1998. She joined the Office of Clinical Pharmacology in 1996 and has held various positions of increasing responsibility since then.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
