Keeping Current on Medical Information and Drug Development

17
Keeping Current on Medical Information and Drug Development for Dry Eye Disease


Gary D. Novack





Key Points



  1. ♦ Clinicians, scientists, and researchers need to keep current on literature.
  2. ♦ The U.S. Food and Drug Administration’s general activities and nonconfidential information (approved products) may be found at www.fda.gov, the European regulatory agency at http://www.emea.eu.int/home.htm, and the Japanese health authority at http://www.mhlw.go.jp/english/.
  3. ♦ Information on the International Conference on Harmonisation can be found at www. ich.org.
  4. ♦ News on publicly traded U.S. companies may be found at www.sec.gov/edgar.
  5. ♦ PubMed, tracking mainly American journals, can be obtained free at www.ncbi.nlm.nih.gov/entrez/query.fcgi.

In this book, experts from around the world provide the latest in clinical diagnosis, management, and treatment of dry eye disease. Much of the guidance comes from relatively recent findings in ocular surface disease and novel therapeutics. As active research continues in all areas related to dry eye, it behooves the clinician to keep current, to provide the best care for his or her patients. In addition, the clinician needs some understanding about how new products are developed and come to market for general use by patients.


♦ Challenges to Keeping Current


We live in a world where the quantity of medical information is increasing at a rapid rate. Each year brings us new medical journals, both for original research and for review articles, as well as new “tabloids,” information services, and directed medical education publications. Anyone with an e-mail address is deluged with notes—some from colleagues and friends, and many more that are seemingly personalized but in reality are advertising in its various forms.


As clinicians, scientists, and researchers, our jobs are multidimensional. Rewards are many, but so are challenges. The tasks that provide the greatest financial compensation may or may not correspond with the effort the compensation. Although we are not compensated in the traditional sense for time spent reading journals and news items, it is a worthwhile and required activity to be the best professionals that we can be. For me, reading the latest medical literature for relevancy to my current research projects is one of my favorite activities. In this chapter, I provide guidance to the clinician on how to keep current on information from the medical literature. Because medical research and practice do not exist in isolation, I also provide guidance on the patent literature, drug and device regulatory activity, and business information. The URLs for Web sites, where available, are provided in Table 17-1.






























































































Table 17-1 Web Sites for Services Described in the Text
Service Web Site
Association for Research in Vision and Ophthalmology www.arvo.org
BioWorld www.bioworld.com
Derwent www.thomsonderwent.com/
DEWS (Dry Eye Workshop) www.tearfilm.org/content/dews/dewshome.html
Dialog www.dialog.com
EMBASE www.embase.com
European Agency for the Evaluation of Medicinal Products www.emea.eu.int/home.htm
European Patent Office www.european-patent-office.org/index.en.php
Eyeworld www.eyeworld.org
Food and Drug Administration (U.S.) www.fda.gov
FDA “push” site* www.fda.gov/cder/cdernew/listserv.html
FDA: Drugs@FDA.gov www.accessdata.fda.gov/scripts/cder/drugsatfda
FDA CDRH: PMAs www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
FDA CDRH: 510k www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
FDA-CDRH Guidance Documents www.fda.gov/cdrh/guidance.html
F-D-C Reports www.fdcreports.com
Health Protection Board (Canada) www.hc-sc.gc.ca/
Ministry of Health, Labor and Welfare (Japan) www.mhlw.go.jp/english
National Eye Institute www.nei.nih.gov
NewsEdge www.newsedge.com
OptiStock www.optistock.com
Prevent Blindness America www.preventblindness.org
PubMED www.ncbi.nlm.nih.gov/entrez/query.fcgi
Securities and Exchange Commission (U.S.) www.sec.gov/edgar.shtml
Sjögren’s Syndrome Foundation www.sjogrens.com
Tear Flow and Ocular Surface Society www.tearfilm.org
U.S. Patent Office www.uspto.gov
Yahoo www.finance.yahoo.com

*The FDA push site will allow you to sign up to receive regular emails on news items of your choice.


 


♦ New Product Development


Although there are many approved therapeutic pharmaceuticals and medical devices for ophthalmology, there are many still underserved areas, especially in ocular surface diseases. It behooves the clinician to understand the development process to better understand which new products might be available for more general use and when.

Related posts:

  1. Patient History, Symptoms, and Questionnaires for Dry Eye Disease
  2. Innovations in the Treatment of Dry Eye Disease: Mucin Stimulators and Hormone Replacement
  3. Increasing Tear Quantity with Artificial Tears and Reducing Evaporation
  4. In-Office Diagnostic Tests for Dry Eye Disease

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Jun 4, 2016 | Posted by in OPHTHALMOLOGY | Comments Off on Keeping Current on Medical Information and Drug Development

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