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FDA guidance
Pharma
FDA looks to clarify follow-up testing mandate for speedy nods
In a draft guidance document, the FDA specified criteria to determine whether a confirmatory trial is “underway” prior to an accelerated approval.
Angus Liu
Jan 6, 2025 3:36pm
Trade groups, pharmas weigh in on new FDA drug shortage guidance
Sep 6, 2022 9:10am