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- FDA releases proposed commitment letter detailing changes to GDUFA IV programThe U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
- Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilatorsHamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…