CPC Comments on CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft Guidance

On April 9, 2019, CPC provided comments on FDA’s proposed CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. Our comment letter asks FDA to provide a number of clarifications in the Draft Guidance, including: (1) confirming that the scope of the Draft Guidance includes combination products under CDER jurisdiction; (2) clarifying how the proposed CDER Program will align with the CDRH Standards and Conformity Assessment Program for the device constituent(s) of combination products under CDER jurisdiction; (3) clarifying how the informal nature of the CDER Program will ensure predictability and consistency across CDER for the same device constituent and the same standard; and (4) clarifying the type of standards that are expected to be a part of the CDER Program.