2014, Government, Provider and Utilities

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2014

Government

Provider

Utilities

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

FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic

Clinic Clinical Practice Provider Utilities

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Especially now with the utility of the use code minimized. Teva decision changed everything.

IT Provider ER Insurance

Primary Care Digest

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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