Postmarketing Adverse Drug Experience Reporting

ICR 202303-0910-017

OMB: 0910-0230

Federal Form Document

Forms and Documents

Document Name	Status
83-C for 0230 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-20
83-C for 0230 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-20
0230 AER for Drugs SSA 2021 REV.docx Supporting Statement A	2021-11-21
0230 AER for Drugs SSA 2021 REV.docx Supporting Statement A	2021-11-21

IC Document Collections

IC ID	Document Title	Status
5821	AER Rx products not subject of marketing application	Unchanged
259219	Postmarketing Safety Reporting for Combination Products	New
250441	GFI: Providing PSURs Other-Agency Guidance	Unchanged
250440	GFI: AER and Records During Pandemic Other-Agency Guidance	Unchanged
234420	AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1)) Other-Agency Guidance	Unchanged
234419	AER under FFDCA sec. 760 - nonprescription drug products Other-Agency Guidance	Unchanged
188678	AER records under 314.80 (marketing applications)	Unchanged
188677	AER records for Rx products not subject of marketing application	Unchanged
188676	AER under 314.80 (marketing applications) - quarterly reports Other-Agency Guidance	Unchanged
188675	AER under 314.80 (marketing applications) - 15 day alerts	Unchanged