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Generic drugs need to be within 20% of specifications of brand name. So, generic and brand names are not the same.
The article reads like an anti-generics opinion piece, and almost accuses the FDA of putting patients lives at risk. Some examples of suggestive language (emphasis added):
Most of it is based on one source and the "potential revisions" section seems to contain only revisions that would benefit patent-holders. Nothing that addresses the dangers to patients mentioned before. DS Belgium ( talk) 20:48, 21 September 2011 (UTC)
I'm not knowledgeable enough about the Act to make the change myself, but the bit about the paragraph I, II, III, and IV certifications is worded misleadingly. "It also sets out the condition [sic] that must be met when someone files an ANDA. The first is [...]. The second is [...]. The third is [...]. Lastly, it is required that [...]." This makes it sound like all four conditions must be satisfied, but this article indicates that only one—any one—of said conditions need be satisfied. Istaro ( talk) 12:16, 2 August 2012 (UTC)
I propose to merge Approved Drug Products with Therapeutic Equivalence Evaluations into this article as its own subsection. The Orange Book is just a creation of this statute. BD2412 T 17:23, 25 April 2020 (UTC)
This article is the subject of an educational assignment at New York University supported by the Wikipedia Ambassador Program during the 2011 Spring term. Further details are available on the course page.
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PrimeBOT (
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This article is rated Start-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | ||||||||||||||||||||||||
|
This article links to one or more target anchors that no longer exist.
Please help fix the broken anchors. You can remove this template after fixing the problems. |
Reporting errors |
Generic drugs need to be within 20% of specifications of brand name. So, generic and brand names are not the same.
The article reads like an anti-generics opinion piece, and almost accuses the FDA of putting patients lives at risk. Some examples of suggestive language (emphasis added):
Most of it is based on one source and the "potential revisions" section seems to contain only revisions that would benefit patent-holders. Nothing that addresses the dangers to patients mentioned before. DS Belgium ( talk) 20:48, 21 September 2011 (UTC)
I'm not knowledgeable enough about the Act to make the change myself, but the bit about the paragraph I, II, III, and IV certifications is worded misleadingly. "It also sets out the condition [sic] that must be met when someone files an ANDA. The first is [...]. The second is [...]. The third is [...]. Lastly, it is required that [...]." This makes it sound like all four conditions must be satisfied, but this article indicates that only one—any one—of said conditions need be satisfied. Istaro ( talk) 12:16, 2 August 2012 (UTC)
I propose to merge Approved Drug Products with Therapeutic Equivalence Evaluations into this article as its own subsection. The Orange Book is just a creation of this statute. BD2412 T 17:23, 25 April 2020 (UTC)
This article is the subject of an educational assignment at New York University supported by the Wikipedia Ambassador Program during the 2011 Spring term. Further details are available on the course page.
The above message was substituted from {{WAP assignment}}
by
PrimeBOT (
talk) on 16:24, 2 January 2023 (UTC)