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2014

Government

Utilities

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

Clinic

Clinic Clinical Practice Provider Utilities

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Especially now with the utility of the use code minimized. The catch is, as we have learned from the GSK v. Teva decision changed everything. But what is a “true carve-out?”

IT Provider ER Insurance

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

Ding Dong is the Skinny Label (Effectively) Dead?

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