Food and Drug Administration approval process for ophthalmic drugs in the US

Current Opinion in Ophthalmology

Volumn 19, Issue 3, 2008, Pages 190-194

  Lloyd, Rhea ^a   Harris, Jennifer ^a   Wadhwa, Sonal ^a   Chambers, Wiley ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biologic license application (BLA); Drug regulation in the US; FDA; New drug application (NDA); Ophthalmic drug approval

Indexed keywords

AGENTS ACTING ON THE EYE; RANIBIZUMAB;

ANGIOGRAPHY; BIOLOGIC LICENSE APPLICATION; CLINICAL STUDY; CLINICAL TRIAL; DRUG APPROVAL; DRUG DESIGN; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; EXPERIMENTAL ANIMAL; FOOD AND DRUG ADMINISTRATION; HUMAN; LICENCE; NONHUMAN; OPTICAL COHERENCE TOMOGRAPHY; ORGANIZATION AND MANAGEMENT; PATIENT SELECTION; PHARMACODYNAMICS; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; TREATMENT PLANNING; UNITED STATES; VISION; VISUAL ACUITY;

DRUG APPROVAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; OPHTHALMIC SOLUTIONS; OPHTHALMOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 42149116888     PISSN: 10408738     EISSN: None     Source Type: Journal    
DOI: 10.1097/ICU.0b013e3282f97fa1     Document Type: Review

References (8)

1. Center for Drug Evaluation and Research. Information on New Drug Application (NDA) process. http://www.fda.gov/cder/regulatory/applications/ default.htm. [Accessed 19 February 2008] This is the primary resource for information on the drug approval process in the US which is updated regularly. Greater detail and guidance for each stage of development may be found at this site.
2. Shima DT, Gougos A, Miller JW, et al. Cloning and mRNA expression of vascular endothelial growth factor in ischemic retinas of Macaca fascicularis. Invest Ophthalmol Vis Sci 1996; 37:1334-1340.
3. Husain D, Kim I, Gauthier D, et al. Safety and efficacy of intravitreal injection of ranibizumab in combination with verteporfin PDT on experimental choroidal neovascularization in the monkey. Arch Ophthalmol 2005; 123:509-516.
4. Krzystolik MG, Afshari MA, Adamis AP, et al. Prevention of experimental choroidal neovascularization with intravitreal antivascular endothelial growth factor antibody fragment. Arch Ophthalmol 2002; 120:338-346.
5. Medical Officer's Review, BLA 125156 Lucentis (ranibizumab injection), June 2006. http://www.fda.gov/cder/foi/nda/2006/125156s0000_Lucentis_MedR.pdf. [Accessed 19 February 2008]
6. Code of Federal Regulations, Title 21, Part 31, section 126 (21CFR31.126). Washington, DC: US Government Printing Office; 2007.
7. Temple R. A regulatory authority's opinion about surrogate endpoints. In: Nimmo WS, Tucker GT, editors. Clinical measurement in drug evaluation. Hoboken: John Wiley & Sons; 1995. pp. 3-22.
8. Code of Federal Regulations, Title 21, Part 31, section 125 (21CFR31.125). Washington, DC: US Government Printing Office; 2007.