The U.S. Food and Drug Administration (FDA) last week announced it expects to launch a new Pharmaceutical Supply Chain Governance Board (SCGB) in September “to facilitate and coordinate all supply chain initiatives across the Center for Drug Evaluation and Research (CDER) and provide strategic guidance on major supply chain issues,” CDER Center Director Patrizia Cavazzoni said in an e-mail to agency staff.
The board will facilitate rapid analysis and resolution of drug supply chain challenges through the following actions:
- Facilitating decision-making across the center as it concerns major supply chain issues with CDER-regulated products
- Providing clear and consistent guidance to generate appropriate response to and communication about major supply chain issues
- Communicating recommendations, decisions, and actions to the CDER director and throughout the center as appropriate
In addition, the SCGB will facilitate and coordinate all new and existing supply chain initiatives across CDER, including the ongoing development of the Drug Supply Chain Surveillance System implemented in fall of 2020. The board will report to Cavazzoni and will be composed of CDER senior leadership, as well as subject matter experts as needed.
For more information about the SCGB or to contact the board with a supply chain-related question or concern, e-mail CDER_SCGB@fda.hhs.gov.
Edited by Michael Causey