AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))

Postmarketing Adverse Drug Experience Reporting

0636 GFI on AER for NonRx Human Drug Products

AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))

OMB: 0910-0230