Comments on: How To Find Documents On The FDA Site http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/ News, Comment and Conversation Fri, 10 Feb 2012 17:51:42 +0000 http://wordpress.org/?v=2.6.2 By: donna http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-75272 donna Wed, 02 Jan 2008 09:13:24 +0000 http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-75272 What's being done about the combination of childhood vaccines shutting down the pancreas if given together to get a child caught up on vaccinations, ie for school attendance or travel? What’s being done about the combination of childhood vaccines shutting down the pancreas if given together to get a child caught up on vaccinations, ie for school attendance or travel?

]]> By: Lisa Van S http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-52292 Lisa Van S Sat, 22 Dec 2007 05:19:13 +0000 http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-52292 Ed, You are gonna need a larger magnifying glass than that.. Ed,

You are gonna need a larger magnifying glass than that..

]]> By: Tom http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-51294 Tom Fri, 21 Dec 2007 17:36:47 +0000 http://www.pharmalot.com/2007/12/how-to-find-documents-on-the-fda-site/#comment-51294 The FDA web site certainly contains a wealth of information, if you know how to find it and evaluate it in the correct scientific and regulatory context. The good news is that FDA has put much effort into soliciting stakeholder feedback on its homepage and has said it plans to increase user-friendliness considerably. For comparative perspectives on drug safety issues, there are four top-tier health authority websites that also offer a huge trove of data and assessments to sift through. They are the European Medicines Agency, Health Canada, UK Medicines Agency, and Australian Therapeutic Goods Administration. Just my opinion, but I think EMEA does the nicest job of remembering that a drug risk has to be assessed against the benefit, not in a vacuum. Health Canada offers both a health professional and a patient version of all safety communications - a useful feature for consumers who may not understand medical jargon. http://www.emea.europa.eu http://www.hc-sc.gc.ca/index_e.html http://www.mhra.gov.uk/ http://www.tga.gov.au/ By the way, anyone who wants to learn more about the significance of liver enzyme elevations in clinical trials might appreciate the new FDA draft guidance on this topic http://www.fda.gov/Cder/guidance/7507dft.htm The FDA web site certainly contains a wealth of information, if you know how to find it and evaluate it in the correct scientific and regulatory context. The good news is that FDA has put much effort into soliciting stakeholder feedback on its homepage and has said it plans to increase user-friendliness considerably. For comparative perspectives on drug safety issues, there are four top-tier health authority websites that also offer a huge trove of data and assessments to sift through. They are the European Medicines Agency, Health Canada, UK Medicines Agency, and Australian Therapeutic Goods Administration. Just my opinion, but I think EMEA does the nicest job of remembering that a drug risk has to be assessed against the benefit, not in a vacuum. Health Canada offers both a health professional and a patient version of all safety communications - a useful feature for consumers who may not understand medical jargon.
http://www.emea.europa.eu
http://www.hc-sc.gc.ca/index_e.html
http://www.mhra.gov.uk/
http://www.tga.gov.au/
By the way, anyone who wants to learn more about the significance of liver enzyme elevations in clinical trials might appreciate the new FDA draft guidance on this topic http://www.fda.gov/Cder/guidance/7507dft.htm

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