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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US FDA’s In-Person Foreign Inspections Remain On House Appropriators’ Minds
The House Appropriations Committee also does not want the agency to become too dependent on alternative inspection tools.
US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead
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.
Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says
Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.