J. Seth Olson

J. Seth Olson

Latham & Watkins LLP

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Recent FDA Guidance Signals Increased Willingness to Engage Industry Stakeholders

The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders. On September 22, 2023, the US...more

10/26/2023  /  Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , PDUFA , Prescription Drugs , Special Meetings , User Fees
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