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Oct

GDUFA III User Fees, Guidances, and MAPPs Published October 5, 2022

There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA.  Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]

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