Formal Meetings with Sponsors and Applicants for PDUFA Products

OMB 0910-0429

OMB 0910-0429

This information collection supplements FDA regulations by providing recommendations to industry on what to include in formal meeting requests between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by FDA.

The latest form for Formal Meetings with Sponsors and Applicants for PDUFA Products expires 2023-05-31 and can be found here.

OMB Details

CDER - Meeting Requests

Federal Enterprise Architecture: Health - Consumer Health and Safety


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