Exclusive: Turnover tsunami at FDA's pharma inspections office puts the backlog in sharp focus
Hiring has always been an issue for the FDA, particularly for those with expertise in pharma and biotech as they can quickly move over to the industry and earn double or triple what they make at the federal agency.
But a recent staff crunch and a surge in the turnover for quality operations inspectors at the FDA this year is becoming particularly noticeable for companies that rely on agency inspections to win approvals, even if the recent case of Novartis and BeiGene missing their PDUFA date due to an inspection was more of an issue with Chinese travel restrictions.
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