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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. I understand that it can be a hard place clinically. We should be able to trust all the data that comes from our governing board. The whole focus was to reduce antipsychotic prescribing. But we should highlight that.

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Loss of DEI Hurts Everyone: Farah Stockman, Ali Thomas, Ken Covinsky

GeriPal

Now to the federal government that is going way beyond what I think people truly understand. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. You look at the physical body and you ask yourself, can you afford to lose diversity? And the uprooting of DEI is an act of violence. Well played.

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