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.
Approved with change |
Reinstatement with change of a previously approved collection | 2020-02-13 | |
Approved without change |
Extension without change of a currently approved collection | 2015-10-21 | |
Approved without change |
Revision of a currently approved collection | 2012-07-20 | |
Approved with change |
Extension without change of a currently approved collection | 2009-06-29 | |
Improperly submitted and continue |
Revision of a currently approved collection | 2009-03-31 | |
Approved without change |
Extension without change of a currently approved collection | 2006-01-26 | |
Approved without change |
Revision of a currently approved collection | 2002-12-23 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 1999-10-28 |
Federal Enterprise Architecture: Health - Consumer Health and Safety