The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action is taken on an application, differing from the norm where the regulatory body would conduct a preapproval inspection of the manufacturing facility to ensure it was in current good manufacturing practice (cGMP) before granting new biologics or drug therapies. Since the COVID-19 pandemic, the FDA has postponed any surveillance inspections, relying on other means to conduct facility assessments; the interim process is expected to last throughout the COVID-19 pandemic, with potential for extension.
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