FDA Appoints New Officers
Joanne Less has become the acting director of the US Food and Drug Administration's Office of Combination Products (OCP).
Joanne Less has become the acting director of the US Food and Drug Administration’s Office of Combination Products (OCP). Less replaces Mark Kramer, who recently resigned as FDA’s director of the OCP. Less is currently the associate director for clinical research and government affairs in the Center for Devices and Radiological Health and is that Center’s expert on the laws, regulations, and policies governing the clinical investigation of medical devices, particularly those related to human subject protection.
Jim Shugars has been named the director for the Office of Information Technology, CDER (OIT–CDER). Jim will report to the FDA CIO and manage the IT staff that supports CDER. Jim has served as acting director for OIT-CDER for over a year. Jim works with a wide range of government and contract personnel in defining, developing, and implementing automated systems.
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.
