FDA Appoints New Officers
FDA has named Virginia Behr as the Center for Drug Evaluation and Research (CDER, www.fda.gov/cder/) ombudsman.
FDA has named Virginia Behr as the Center for Drug Evaluation and Research (CDER, www.fda.gov/cder/) ombudsman. Behr has been with the agency since 1999 and before joining the FDA she worked at the National Institutes of Health (NIH) and Uniformed Services University of the Health Sciences (USUHS) investigating the electrophysiological bases of stimulant drug preference. Behr has been serving as the acting CDER ombudsman for the past four months.
The agency has also selected Edward Cox as director for the Office of Antimicrobial Products (OAP). Cox has been serving as the acting director for OAP since August of 2006. Cox graduated from the University of North Carolina at Chapel Hill and received his medical education at the University of North Carolina School of Medicine.
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.
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.
