GDUFA III: Some Goals May Be Measured In Business Days Instead Of Calendar Days
FDA Officials Also Worried About FDARA Provision Limiting Spending
ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.
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Increasing number of product development meetings suggests that many complex generics remain in the development stages.
Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.