BOSTON — Several new laws – encompassing the next five years of biopharma industry user fees and some add-ons to federal government funding – set up some major changes for the FDA when it comes to biopharma quality.
As part of what’s known as the Food and Drug Omnibus Reform Act or FDORA, Ashley Boam, director of the office of policy in FDA’s Office of Pharmaceutical Quality, explained to attendees at DIA’s 2023 annual conference on Tuesday how there are new risk factors that can be used to prioritize certain inspections of pharma manufacturing sites, but it remains to be seen how that will work in practice.
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