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City Rockville / / Company Structured Product Labeling Resources / FD&C Act / / Country Japan / United States / / Currency USD / / / Event FDA Phase / / Facility Rockville Pike / / IndustryTerm physical media / biological products / products / drug product / nonprescription drug products / Web-based form / prescription drug products / nonprescription product / nonprescription human drug products / human biological products / human drug products / to nonprescription products / Web-based electronic submission portal / nonprescription products / biological product / Web-Based Submission Portal / vaccine products / biological license applications / nonapplication product / pharmaceutical / eSubmitter tool / pharmacovigilance tools / drug/device / nonvaccine products / prescription product / biological product/ device / anatomical site / device combination products / nonvaccine biological products / drug/biological product / combination product / suspect medical product / Web-based electronic form / metal cans / Web-based system / nonvaccine biological product / device products / pharmaceutical products / equipment startup / to biological product / Web-based portal / combination products / drug products / law / to prescription products / / MedicalCondition illness / / MedicalTreatment Dietary Supplement / blood transfusion / vaccination / / Organization Food and Drug Administration / FDA’s ESG / Council for International Organizations of Medical Sciences / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Congress / European Union / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Electronic Submission Requirements AGENCY / / Person Silver Spring / Leslie Kux / / / Position FAERS Electronic Submissions Coordinator / reporter information section / Assistant Commissioner for Policy / responsible physician / Governor / reporter / initial reporter / / Product DSK67QTVN1PROD / human drug / OTC drug / / ProvinceOrState Maryland / Indiana / / PublishedMedium the OTC Drug Monograph Review / Public Law / / Technology pdf / digital certificate / http / / URL http / SocialTag