Mutual Recognition's Next Evolution May Be Sharing Info On India And China Inspections
Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.
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Agency inspectors worked in the country for about a month before the coronavirus infection surge forced another halt.
Until the coronavirus forced it to stop, the FDA had planned to up domestic and foreign inspections in FY 2020 and FY 2021, as the longer-term trend showed domestic inspections dropping and foreign inspections rising.
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.