Emerging Technology Approvals Among FDA Office of Pharmaceutical Quality’s First-Year Achievements

The positive impact that FDA’s Office of Pharmaceutical Quality (OPQ) has had during its first year in operation includes the extra support the agency has been able to provide for emerging technologies, as witnessed by the agency’s first approvals of drug products using continuous manufacturing and 3D printing.

Making the rounds at various conferences to report on the progress OPQ has made in restructuring and retooling the quality regulatory processes at FDA’s Center for Drug Evaluation and Research (CDER), OPQ Deputy Director Lawrence Yu stressed the support his office is able to provide to those implementing new technologies, citing the continuous manufacturing and 3D printing approvals as cases in point.

Yu emphasized that a combination of the new team-based review process and a focus on emerging technologies within OPQ enabled the two approvals to take place smoothly. 

Despite the newness of the concept, “we approved the continuous manufacturing application without a single day delay,” he commented at the Generic Pharmaceutical Association (GPhA) Fall Technical Conference in early November in Bethesda, Maryland.

He invited the generics industry to take advantage of the help the agency can now offer in achieving the benefits of improved process capability.  Noting the reports from innovator companies like Amgen and Lilly on their process capability improvements, Yu commented that “there is no reason you cannot do it.”

In his presentation at GPhA, Yu provided a look at OPQ’s accomplishments during its first ten months in operation.  He addressed: ● OPQ’s structure ● the concept of “one quality voice” ● the quality matrix approach being used ● OPQ’s objectives and the progress to date in achieving them ● other accomplishments in 2015 ● a comparison of the success of the Prescription Drug User Fee Act (PDUFA) after 20 years and the parallel promises the Generic Drug User Fee Act (GDUFA) holds, and ● the benefits of six sigma.

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