FDA Announces Two New Appointments
Dr. Arzu Selen joins FDA's Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics.
Dr. Arzu Selen joins FDA’s Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics. Since joining FDA in 1997, Selen has been in the office of clinical pharmacology and has been actively involved in several FDA initiatives related to pediatrics.
Dr. Julie Beitz has been appointed as the director for the Office of Drug Evaluation III (Rockville, MD, www.fda.gov/cder). Beitz has had a 12-year career at FDA involving both pre- and post-approval regulatory activities. Since January 2006, she has served as the acting director of the Office of Drug Evaluation III.
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.
