Anthony Fanucci

Anthony Fanucci

Alston & Bird

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FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA

On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug...more

9/11/2023  /  Compliance , Draft Guidance , Food and Drug Administration (FDA) , GDUFA , Manufacturers , Manufacturing Facilities , Warning Letters
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