FDA Wants To Restart Domestic On-Site Inspections On July 20 – But There Are Caveats
Agency devises COVID-19 Advisory Rating System to help it determine whether to send investigators to manufacturing facilities
US FDA commissioner Stephen Hahn said on 10 July that the agency has a plan to send investigators back into the field in 10 days. Whether or not a company is inspected, however, will depend on local COVID-19 conditions.
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Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus
William Maisel says FDA investigators are putting their best foot forward when conducting facility inspections amidst the coronavirus pandemic.
‘What, Me Worry?’: Experts Say They’re Not Concerned About FDA Restarting Domestic Inspections Amidst COVID-19
In a few days the US FDA will fire up its domestic inspectorate for the first time since March. But is it a good idea? Three industry experts said during a Food and Drug Law Institute webinar that they’re not particularly worried.
US House Panel Votes For 5.8% Cut In FDA Device Center’s 2021 Budget Authority, Seeks COVID-19 Review
While the House Appropriations Committee is calling for a 5.8% cut in the FDA device center’s budget authority, it nevertheless gives a boost to the agency’s medical device safety and cybersecurity functions.