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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

An extended release (“ER”) opioid in legitimate pain management generally accompanies an IR opioid, with patients taking the ER opioid on a set schedule and the IR opioid as needed. Immediate Release Opioids A prescription for immediate release (“IR”) opioids on a set schedule or for a certain length of time. Complaint ¶ 64.

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CDC Proposes Updating Practice Guideline for Prescribing Opioids, Warning Against Continued Misapplication

FDA Law Blog

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. ER/LA opioids should be “reserved for severe, continuous pain.”.

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CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care

FDA Law Blog

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). ER/LA opioids should be “reserved for severe, continuous pain.”. Methadone should not be the first choice for an ER/LA opioid. 2022 Guideline at 15. (We 2022 Guideline at 3.

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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Instead, it was GSK who erred in omitting the post-MI language from the use code. Amarin even sued a health insurer alleging active encouragement to use Hikma’s generic version instead of Vascepa for the patented indication. Par also has filed similar litigation.

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The Promise and Pitfalls of AI in Medicine: Guest Bob Wachter

GeriPal

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” maybe eight or 10 months ago, “Please write a prior authorization to the insurance company. ” Now, that of course is wacky.

IT 139