OPQ Planning to Extend Its Product Quality Benefit-Risk Framework

The FDA’s Office of Pharmaceutical Quality is working to rebalance views on measuring risks versus benefits.

OPQ’s Product Quality Benefit-Risk Framework project, launched in 2014, aims to ensure that both aspects are effectively factored into overall product assessments early in the review process, said Wendy Wilson-Lee, acting branch chief of the OPQ’s Office of New Drug Products.

The program, which entered its second phase in January, currently looks at select NDAs and assesses the potential impact of each critical deficiency or safety issue on patient outcomes.