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![]() | The contents of the Summary of Product Characteristics page were merged into Medication package insert. For the contribution history and old versions of the redirected page, please see its history; for the discussion at that location, see its talk page. |
![]() | The contents of the Patient information leaflet page were merged into Medication package insert. For the contribution history and old versions of the redirected page, please see its history; for the discussion at that location, see its talk page. |
One of the general controversies for PIs (that is, not related to the PI for any specific medication) is that the manufacturer cannot include statements without the regulatory agency's approval, but can be sued for product liability (in the US, at least) for not providing the same information that the agency prohibited them from providing. It works like this:
Drug Co. is, basically, left with a choice between breaking the law, paying damages, or protesting the decision by halting manufacture of the drug if the FDA doesn't let them claim weakly supported side effects. The regulatory agency has a public interest in not allowing the manufacturer to spam every possible side effect into the PI, since it wants prescribers and patients to get useful information (and if the decision were entirely up to the manufacturer's product liability lawyers, then some of them really would list every possible side effect on every single medication).
I know this has been discussed in sources, but I don't have any at hand. If someone else has sources, then perhaps this could be addressed in this article. WhatamIdoing ( talk) 23:22, 24 May 2010 (UTC)
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In October of 2017 it was proposed that Patient information leaflet be merged into this article. There have been no negative response so the articles have been merged. Pkgx ( talk) 16:55, 25 January 2018 (UTC)
In: The list of 1997 drug labelling changes can be found on the FDA's website, here. Gevrey ( talk) 21:33, 8 June 2022 (UTC)
![]() | This article is rated Start-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | ||||||||||||||||||||
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![]() | The contents of the Summary of Product Characteristics page were merged into Medication package insert. For the contribution history and old versions of the redirected page, please see its history; for the discussion at that location, see its talk page. |
![]() | The contents of the Patient information leaflet page were merged into Medication package insert. For the contribution history and old versions of the redirected page, please see its history; for the discussion at that location, see its talk page. |
One of the general controversies for PIs (that is, not related to the PI for any specific medication) is that the manufacturer cannot include statements without the regulatory agency's approval, but can be sued for product liability (in the US, at least) for not providing the same information that the agency prohibited them from providing. It works like this:
Drug Co. is, basically, left with a choice between breaking the law, paying damages, or protesting the decision by halting manufacture of the drug if the FDA doesn't let them claim weakly supported side effects. The regulatory agency has a public interest in not allowing the manufacturer to spam every possible side effect into the PI, since it wants prescribers and patients to get useful information (and if the decision were entirely up to the manufacturer's product liability lawyers, then some of them really would list every possible side effect on every single medication).
I know this has been discussed in sources, but I don't have any at hand. If someone else has sources, then perhaps this could be addressed in this article. WhatamIdoing ( talk) 23:22, 24 May 2010 (UTC)
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Cheers.— InternetArchiveBot ( Report bug) 09:38, 24 January 2018 (UTC)
In October of 2017 it was proposed that Patient information leaflet be merged into this article. There have been no negative response so the articles have been merged. Pkgx ( talk) 16:55, 25 January 2018 (UTC)
In: The list of 1997 drug labelling changes can be found on the FDA's website, here. Gevrey ( talk) 21:33, 8 June 2022 (UTC)