Regulatory aspects of drug approval for macular degeneration

Advanced Drug Delivery Reviews

Volumn 57, Issue 14 SPEC. ISS., 2005, Pages 2092-2098

  Gryziewicz, Lewis ^a  

^a ALLERGAN INC   (United States)

Author keywords

AMD; Macular degeneration; Neovascular form

Indexed keywords

BLOOD; DETERIORATION; DISEASES; DRUG PRODUCTS; PATHOLOGY;

ABNORMAL BLOOD VESSELS; AMD; MACULAR DEGENERATION; NEOVASCULAR FORM;

CONTROLLED DRUG DELIVERY;

BENZOPORPHYRIN DERIVATIVE; OLIGONUCLEOTIDE; PEGAPTANIB; PHOTOSENSITIZING AGENT;

CLINICAL TRIAL; DOSE RESPONSE; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG MARKETING; DRUG RELEASE; FOOD AND DRUG ADMINISTRATION; HUMAN; LIGHT; NONHUMAN; PHOTODYNAMIC THERAPY; PRIORITY JOURNAL; RETINA MACULA AGE RELATED DEGENERATION; RETINA MACULA DEGENERATION; RETINA NEOVASCULARIZATION; REVIEW; SUBRETINAL NEOVASCULARIZATION;

EID: 28444434771     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2005.09.009     Document Type: Review

References (13)

1. FDA Briefing Package for August 27, 2004 FDA Advisory Committee Meeting. Available at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004- 4053B1_02_FDA-Backgrounder.htm.
2. Visudyne Package Insert. Seattle, WA: QLT PhotoTherapeutics, Inc., 2003.
3. Eyetech Pharmaceuticals, Inc. Briefing Package for August 27, 2004 FDA Advisory Committee Meeting. Available at: http://www.fda.gov/ohrms/dockets/ac/ 04/briefing/2004-4053b1.htm.
4. M. Matthieu New Drug Development: A Regulatory Overview Sixth edition 2000 Parexel International Corporation Waltham, MA
5. R.A. Guarino New Drug Approval Process Third edition 2000 Marcel Dekker, Inc. New York, NY
6. ICH Harmonized Tripartite Guidance, Guideline for Good Clinical Practice, E6, May 1, 1996. Available at: http://www.ich.org/cache/compo/276-254-1.html.
7. Visudyne Advisory Committee meeting transcript. Available at: http://www/fda.gov/ohrms/dockets/ac/cder99t. htm#Dermatologic%20and%20Ophthalmic%20Drugs%20Advisory%20Committee.
8. FDA Visudyne Summary Basis of Approval. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction= Search.Label_ApprovalHistory#apphist.
9. Visudyne Summary of Product Characteristics. Available at: http://www.emea.eu.int/humandocs/Humans/EPAR/visudyne/visudyneM.htm.
10. Visudyne CPMP Review. Available at: http://www.emea.eu.int/humandocs/ Humans/EPAR/visudyne/visudyneM.htm.
11. FDA Macugen Summary Basis of Approval. Available at: http://www. accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. Label_ApprovalHistory#apphist.
12. FDA Manual of Standard Oprating Procedures and Policies, Intercenter Consultative/Collaborative Review Process, June 18, 2004. Available at: http://www.fda.gov/oc/combination/intercentersop.html.
13. Assignment of Agency Component for Review of Premarket Applications, Federal Register, Vol. 68, No. 120, June 23, 2003. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-15698.html.