In February 2019, CDER outlined a program via draft guidance where stakeholders can propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical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 for all drugs, including brand, generics, biologics, biosimilars, and over-the-counter drugs. It will help create efficiencies in generic and biosimilar manufacturing which is an important part of streamlining generic and biosimilar development and spurring competition as part of our Drug Competition Action Plan (DCAP) and Biosimilars Action Plan. Please see this CDER Conversation, where Pallavi Nithyanandan, director of the Compendial Operations and Standards Staff in CDER’s Office of Pharmaceutical Quality, speaks about the program, how stakeholders can participate, and how the program may provide industry with additional resources for pharmaceutical development and manufacturing.
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