title: Food and Drug Administration approval process for ophthalmic drugs in the US.
abstract: OBJECTIVE
  The purpose of this review is to provide the overall framework of the review and approval of ophthalmic drugs in the US.
  
  
  RESULTS
  Examples from the recent approval of the ranibizumab injection (Lucentis; Genentech, South San Francisco, California, USA) are offered to illustrate the current approval process at the Food and Drug Administration (FDA).
  
  
  CONCLUSIONS
  New drugs are brought to the US market after review of the New Drug Application or Biologic License Application by the FDA. This review process requires the teamwork of an interdisciplinary team of clinicians, scientists and regulatory personnel. This team is ultimately responsible for recommending to the Secretary of Health and Human Services (or designee) the approvability of a drug based on defined requirements including the drug's risk/benefit profile, quality and purity, and the drug's ability to be labeled effectively. Within the Center for Drug Evaluation and Research this review team for ophthalmic drugs resides primarily within the Division of Anti-Infective and Ophthalmology Products.
authors.affiliation: Division of Anti-Infective and Ophthalmology Products, US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20903, USA. Rhea.Lloyd@fda.hhs.gov
authors.forename: Rhea
authors.initials: R
authors.lastname: Lloyd
authors.forename: Jennifer
authors.initials: J
authors.lastname: Harris
authors.forename: Sonal
authors.initials: S
authors.lastname: Wadhwa
authors.forename: Wiley
authors.initials: W
authors.lastname: Chambers
mesh_terms: D017277:Drug Approval / Q000379:methods*; D006801:Humans; D017387:Investigational New Drug Application; D009883:Ophthalmic Solutions; D009885:Ophthalmology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009883:Ophthalmic Solutions