title: FDA guidance document on monitoring delayed adverse events a good first start.
authors.forename: David A
authors.initials: DA
authors.lastname: Williams
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D002986:Clinical Trials as Topic; D017277:Drug Approval; D015316:Genetic Therapy / Q000379:methods; D006801:Humans; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration