CDER Conversations
Interviews with CDER experts on priorities, projects, and initiatives
CDER Conversation: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
In February 2019, CDER outlined a program via draft guidance where stakeholders can propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Today, CDER is issuing the final guidance for this program, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, and launching a new portal to submit standards for potential recognition. This program is intended to promote innovation in pharmaceutical development and manufacturing.
In this CDER Conversation, we speak with Pallavi Nithyanandan, director of the Compendial Operations and Standards Staff in the Office of Pharmaceutical Quality, about the program, how stakeholders can participate, and how the program may provide industry with additional resources for pharmaceutical development and manufacturing.