title: Bioanalytical inspections: organizational changes and regulatory perspectives.
authors.affiliation: US Food & Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors.forename: Sam H
authors.initials: SH
authors.lastname: Haidar
authors.affiliation: US Food & Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors.forename: Kara A
authors.initials: KA
authors.lastname: Scheibner
mesh_terms: D057134:Antibodies, Neutralizing / Q000032:analysis; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000032:analysis*; D004335:Drug and Narcotic Control / Q000379:methods / Q000458:organization & administration; D006801:Humans; D007109:Immunity; D007118:Immunoassay / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D057134:Antibodies, Neutralizing; D059451:Biosimilar Pharmaceuticals
keywords: US FDA; batch acceptance; biosimilars; extract stability; immunogenicity testing; regulatory