Susan C. Winckler has been named the agency's acting chief of staff.
Susan C. Winckler has been named the agency’s acting chief of staff. Winckler replaces Patrick Ronan who announced his resignation after several years of service at the FDA. In her new role, Susan will coordinate staff activities in the Office of the Commissioner and serve as the principal liaison to the Department of health and Human services. Susan joined FDA in September 2006 as the director of policy communications, in the Office of Policy and Planning within the Office of the Commissioner.
Dr. Blair Fraser has been selected as division director, Division of Pre-marketing Assessment I, Office of New Drug Quality Assessment (ONDQA). In 2004, Fraser joined Office of New Drug Chemistry and served as deputy director in division 2, and since November 2005 he has worked as chief, Branch II, Division of Pre-marketing Assessment I, ONDQA.
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.