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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

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. Instead, it was GSK who erred in omitting the post-MI language from the use code. Par also has filed similar litigation.

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Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

The pneumonia could get treated, but I think geriatricians, actually, were well aware of iatrogenic complications of care and quality gaps, even well before the IOM reports of the late 1990s and the like. Patients will come into the ER, they bypass the inpatient experience entirely, and go straight home. And that’s more standard.

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