The 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 theÂ assessment identifiedÂ quality and safety compliance problems at a cell-therapy production laboratory and a radiopharmaceutical compoundÂ production facility.
The agency suspended operations at the facilities and haltedÂ enrollment of patients for clinical trials of the affected experimental drugs.
NIH formed a working group in December to develop management strategies forÂ the agency’sÂ Clinical Center Pharmaceutical Development Section and its affiliatedÂ labs and productionÂ hubs afterÂ theÂ Food and Drug AdministrationÂ found seriousÂ quality-control problems within PDS.
TheÂ Clinical Center Working Group was scheduled Thursday to submit its recommendations to NIH.