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Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)

FDA Law

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. Moreover, there are some significant limitations to the application of this delay provision that appear to make it difficult to utilize. Each product is limited to two years of delay.

IT 52
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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

But the thing that really motivates me is seeing, you know, and trying to manage later stage, you know, we can call them complications of people who haven’t had a diagnosis are now really in, you know, a world of complexity around other conditions, around managing life and managing practical things. Ana chodos, what should I be?

Screening 119
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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement.

IT 52