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Talk:Specialty drugs in the United States

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REMS and Breakthrough therapy as part of Specialty Drug definition

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I believe the REMS status, and the Breakthrough Therapy designation should also be listed in the Definition and common characteristics section of this "Specialty drugs" article. This stood out to me when I noticed the item "3 AARP" seems to be out of order. It should probably be part of section 3.3.

So back to my first point would change section 1 to the following:

1 Definition and common characteristics 

   1.1 High cost
   1.2 High complexity
   1.3 High touch
   1.4 Limited availability
   1.5 Rare and complex diseases
   1.6 REMS status
   1.7 Breakthrough therapy

and the details under 1.6 and 1.7 headings as follows

1.6 REMS status 

   A drug requiring a risk evaluation and mitigation strategy to minimize the risk to patients.

1.7 Breakthrough therapy 

   A drug that has had very promising phase2 rather than phase3 clinical trial results, allowing early introduction of a much needed therapy to the market.

Note: Sections 3.1 and 3.2 should remain as currently exist in the article.

Note2: I am not citing sources since there is no existing formal standard definition for "Specialty Drugs". First I am attempting to promote a discussion on the need to more closely define the criterion for specialty drugs by including REMS and Breakthrough Therapy in that section, and Second to clean up the article in that I believe the AARP section is miss-placed.

RStem (talk) 16:37, 13 March 2019 (UTC)[reply]

Title and creating a specialty drugs page not limited to US

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I understand the (current) redirect from specialty drugs to this page, since the article is fairly focused on the US situation. However, there really should be a page for specialty drugs in general, since these drugs are being produced and used around the world.--Wuerzele (talk) 23:12, 15 May 2022 (UTC)[reply]

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