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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. You know, most, most ERs admit, you know, far fewer than 50% of their patients. They go to observation and go home or just get discharged straight from the ER? So we try a pilot.

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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

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. Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired.

IT 52