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FDA warns CRO data-integrity problems can delay ANDAs; OGD recruiting staff
Summary
Darby Kozak said data-integrity investigations at contract research organizations have been the top cause of missed ANDA goal dates and sometimes require applicants to repeat studies; she also announced active recruitment for pharmaceutical and public-health professionals at OGD.
Kozak identified data integrity problems at contract research organizations as the number-one issue driving missed goal dates. She said FDA investigations not only delayed ANDAs that used the affected CRO but in some cases required applicants to repeat studies, and she urged applicants to vet CROs carefully to avoid such setbacks.
Kozak also announced that OGD is actively hiring pharmaceutical and public-health professionals and invited U.S. citizens and permanent residents to submit CVs to ogdjobsfda.hhs.gov. She framed recruitment as part of the office's effort to maintain review quality and capacity while reducing backlogs and missed goals.
