Formal Meetings with Sponsors and Applicants for PDUFA Products

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.

Latest Forms, Documents, and Supporting Material

Document Name
CDER - Meeting Requests
CBER - Information Packages
CDER - Information Packages
CBER- Meeting Requests

All Historical Document Collections

202002-0910-002 Approved with change	Reinstatement with change of a previously approved collection	2020-02-13
201510-0910-004 Approved without change	Extension without change of a currently approved collection	2015-10-21
201207-0910-007 Approved without change	Revision of a currently approved collection	2012-07-20
200906-0910-004 Approved with change	Extension without change of a currently approved collection	2009-06-29
200903-0910-009 Improperly submitted and continue	Revision of a currently approved collection	2009-03-31
200601-0910-002 Approved without change	Extension without change of a currently approved collection	2006-01-26
200212-0910-004 Approved without change	Revision of a currently approved collection	2002-12-23
199910-0910-009 Approved without change	New collection (Request for a new OMB Control Number)	1999-10-28

OMB Details

CDER - Meeting Requests

Federal Enterprise Architecture: Health - Consumer Health and Safety