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NIH Review Aims to Address Quality Control Concerns Over Clinical Drug Production

HealthThe National Institutes of Health has partnered with two companies to evaluate agency facilities that produce sterile or infused medicines for clinical research use.

NIH said Tuesday preliminary findings of the assessment identified quality and safety compliance problems at a cell-therapy production laboratory and a radiopharmaceutical compound production facility.

The agency suspended operations at the facilities and halted enrollment of patients for clinical trials of the affected experimental drugs.

NIH formed a working group in December to develop management strategies for the agency’s Clinical Center Pharmaceutical Development Section and its affiliated labs and production hubs after the Food and Drug Administration found serious quality-control problems within PDS.

The Clinical Center Working Group was scheduled Thursday to submit its recommendations to NIH.

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