Goldberger to Head New CBER Pandemic Flu Program
Mark Goldberger has been named the first medical director for Emerging and Pandemic Threat Preparedness at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.
Mark Goldberger has been named the first medical director for Emerging and Pandemic Threat Preparedness at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. In his new position, Goldberger will assume responsibility for CBER’s pandemic flu program and will coordinate and implement all programs related to developing and evaluating products for emerging and pandemic threats. Goldberger will also chair CBER’s Pandemic Influenza Steering Committee. Employed at FDA since 1989, Goldberger recently served as director of the Office of Center for Drug Evaluation and Research’s (CDER) Office of Antimicrobial Products.
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.
