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In the worst-case scenario, where new variants emerge and/or new pandemic-related challenges occur, the agency said it would continue to rely more heavily on alternative oversight tools.
The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September.
A worker at Eli Lilly’s Branchburg, N.J., facility filed an anonymous complaint last month, alleging improper conduct at the manufacturing site, a location that’s previously been the subject of FDA scrutiny. The company’s response is that its COVID-19 neutralizing antibody commitments are still on track.
