OMB control number

Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

OMB 0910-0636 · HHS/FDA.

OMB 0910-0636

Latest Forms, Documents, and Supporting Material

Document Name
GUIDANCE 0636.pdf Supplementary Document
SUPPORTING STATEMENT FINAL 0636 6-26-2015.doc Supporting Statement A
Recordkeeping
Reports of Serious Adverse Drug Events

All Historical Document Collections

201506-0910-032 Approved without change	Extension without change of a currently approved collection	2015-07-02
201206-0910-002 Approved without change	Extension without change of a currently approved collection	2012-06-08
200810-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	2008-10-08