title: Monitoring drug product quality.
authors.affiliation: FDA, Rockville, Md.
authors.forename: G
authors.initials: G
authors.lastname: Bolger
authors.forename: R
authors.initials: R
authors.lastname: Goetsch
authors.forename: P
authors.initials: P
authors.lastname: Reinstein
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration