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 | Type |
|---|---|
 GUIDANCE 0636.pdf | Supplementary Document |
 SUPPORTING STATEMENT FINAL 0636 6-26-2015.doc | Supporting Statement A |
 Recordkeeping |
Information collection |
| Reports of Serious Adverse Drug Events |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201506-0910-032 | Extension without change of a currently approved collection | 2015-07-02 | Approved without change | |
| 201206-0910-002 | Extension without change of a currently approved collection | 2012-06-08 | Approved without change | |
| 200810-0910-002 | New collection (Request for a new OMB Control Number) | 2008-10-08 | Approved without change |