OMB control number
Proposed Rule - Adverse Drug Experience Reporting Requirements For Marketed Prescription Drugs Without Approved New Drug Or Abbreviated New Drug Applications
OMB 0910-0210 · HHS/FDA.
OMB 0910-0210
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 198606-0910-002 | No material or nonsubstantive change to a currently approved collection | 1986-06-24 | Approved with change | |
| 198503-0910-004 | New collection (Request for a new OMB Control Number) | 1985-03-25 | Approved without change |