APPENDIX A1: [COMPLETENESS] DRUGS, BIOLOGICS, DEVICES
Drug/Biologic: Is the drug / biologic marketed in the United States (FDA approved)? [If more than one product, check all that apply and include any clarifications in the comments] Yes, continue to 2b. No, continue to Section B( If not marketed in the US, product is investigational and study must be conducted under an IND ................
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