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.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.