Food and Drug Administration approval process for ophthalmic drugs in the US.
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.
Lloyd
Rhea
R
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
Harris
Jennifer
J
Wadhwa
Sonal
S
Chambers
Wiley
W
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
D009883:Ophthalmic Solutions