Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties
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.
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The House Appropriations Committee also does not want the agency to become too dependent on alternative inspection tools.
CDER approved a record 27 novel agents between January and June, while a wave of cell therapy and vaccine applications could carry the biologics center to new heights. Merck could close year with four novel approvals.
Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.