Postmarketing Adverse Drug Experience Reporting

OMB 0910-0230

OMB 0910-0230

FDA regulations require the reporting to FDA of important adverse drug experience information associated with the use of unapproved-marketed prescription drug product. This information is used by FDA to determine at the earliest possible time whether to request a manufacturer, packer, or distributor to recall a product from the market or to recommend a seizure or injunction action to halt the marketing of the product and to remove it from the market. Such action, initiated promptly, may avert further adverse effects that may be associated with the use of the product.

The latest form for Postmarketing Adverse Drug Experience Reporting expires 2021-12-31 and can be found here.

All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2023-03-20
Approved without change
Revision of a currently approved collection 2021-11-22
Approved without change
No material or nonsubstantive change to a currently approved collection 2021-05-26
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-08-03
Approved without change
Revision of a currently approved collection 2018-12-06
Approved without change
Extension without change of a currently approved collection 2015-07-01
Approved without change
Revision of a currently approved collection 2012-07-05
Approved with change
Extension without change of a currently approved collection 2009-04-02
Approved without change
Extension without change of a currently approved collection 2006-02-14
Approved with change
Extension without change of a currently approved collection 2002-07-31
Approved without change
Reinstatement with change of a previously approved collection 1999-03-25
Approved with change
No material or nonsubstantive change to a currently approved collection 1993-05-25
Approved without change
Revision of a currently approved collection 1993-02-25
Approved without change
Reinstatement with change of a previously approved collection 1992-08-27
Approved without change
New collection (Request for a new OMB Control Number) 1986-05-29
OMB Details

Adverse Drug Experience Reporting -- 310.305(c)(5)

Federal Enterprise Architecture: Health - Public Health Monitoring


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