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FDA’s OPQ Emerging Tech Program Plans to Help Sponsors Avoid Manufacturing Quality Failures

June 27, 2017

The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation.

Two-thirds of drug shortages resulted from product-specific quality failures or general manufacturing quality issues, said Lucinda Buhse, director of the Office of Testing and Research in CDER’s Office of Pharmaceutical Quality. Product recalls have also surged in recent years, Buhse said, during the DIA’s annual meeting in Chicago this week.

In addition, the OPQ program can help facilitate new clinical advances by developing the expertise to approve a wider range of novel doses, formulations and combinations — a necessity as treatments begin to trend toward personalized medicine and therapies tailored for individual patients, she said.

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