title: Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
abstract: Impurities in drug substances and drug products have been important regulatory issues in the Office of Generic Drugs by having significant impact on the approvability of Abbreviated New Drug Application (ANDAs). This review begins with a discussion of ANDAs and its similarity/differences with NDAs, highlighting the importance of control of pharmaceutical impurities in generic drug product development and regulatory assessment. An overview of the FDA draft guidance documents "ANDAs: Impurities in Drug Substances" and "ANDAs: Impurities in Drug Products" are provided. This introduces the identification and qualification procedures for ANDAs and approaches to the establishment of acceptance criteria for both drug substance and drug product. Case studies included in this review illustrate the proposed pathway for determination of impurities and their acceptance criteria, based upon the general principles of these guidances.
authors.affiliation: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA. arup.basak@fda.hhs.gov
authors.forename: Arup K
authors.initials: AK
authors.lastname: Basak
authors.forename: Andre S
authors.initials: AS
authors.lastname: Raw
authors.forename: Ali H
authors.initials: AH
authors.lastname: Al Hakim
authors.forename: Scott
authors.initials: S
authors.lastname: Furness
authors.forename: Nashed I
authors.initials: NI
authors.lastname: Samaan
authors.forename: Devinder S
authors.initials: DS
authors.lastname: Gill
authors.forename: Hasmukh B
authors.initials: HB
authors.lastname: Patel
authors.forename: Roslyn F
authors.initials: RF
authors.lastname: Powers
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yu
mesh_terms: D017277:Drug Approval; D004340:Drug Contamination / Q000331:legislation & jurisprudence* / Q000517:prevention & control; D016568:Drugs, Generic / Q000032:analysis; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic