Proposed Rule - Adverse Drug Experience Reporting Requirements For Marketed Prescription Drugs Without Approved New Drug Or Abbreviated New Drug Applications

OMB 0910-0210

Latest Forms, Documents, and Supporting Material

Document Name
PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS

All Historical Document Collections

198606-0910-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1986-06-24
198503-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	1985-03-25