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Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties

 
• By Derrick Gingery

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.

Facility inspection
Sponsors want to make the FDA comfortable with conducting facility inspections, even with the pandemic ongoing. • Source: Shutterstock

With inspections still largely in limbo because of the coronavirus pandemic, drug sponsors are wondering how they can assure the US Food and Drug Administration that their facilities are safe for an inspection and break a logjam of delayed product approvals.

One idea was to develop plans to accommodate in-person inspections

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