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AER under 314.80 (marketing applications) - quarterly reports
Postmarketing Adverse Drug Experience Reporting
0230 GFI Periodic Postmarket Reports in ICH E2C(R2) Format
AER under 314.80 (marketing applications) - quarterly reports
OMB: 0910-0230
OMB.report
HHS/FDA
OMB 0910-0230
ICR 202303-0910-017
IC 188676
AER under 314.80 (marketing applications) - quarterly reports
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⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0230 can be found here:
2025-01-23 - Revision of a currently approved collection
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