Lexology April 1, 2025
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts and their subsequent effects may be leading some companies to consider developing drugs abroad, such ex-US development can come with risks, necessitating upfront planning and compliance controls.
In February 2025, probationary workers at FDA were fired as part of the staffing cuts across the US federal executive branch. While some employees were subsequently asked back, on March 27 the US Department of Health and Human Services (HHS) announced a departmental consolidation and reduction in work force of 10,000 people, which may impact 3,500 full-time FDA employees—about 19% of the agency’s workforce....
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