FDA Law

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. CMS estimated a savings of $1.6 Becerra, No.

Hospital 52

Hospital Government Provider IT 52

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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Medical Diagnosis Healthcare Clinic 53

FDA Law

MAY 21, 2024

What, if Any, Risk There Is to the Public Health HHS found based on an evaluation of various epidemiological databases for emergency department visits, hospitalizations, unintentional exposures, and overdose deaths that public health risks posed by marijuana are low compared to other drugs of abuse. Basis at 45; NPRM at 44,613.

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Physicals Medical Clinic Emergency Room 69

FDA Law

DECEMBER 14, 2023

They contended that access to cannabis is associated with reduced rates of: Opioid use and abuse; Opioid-related hospitalizations; Opioid-related traffic fatalities; Opioid-related drug treatment admissions; and Opioid-related overdose deaths. In other words, a prescription written by a DEA-registered, state-licensed practitioner.

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Medical Manufacturing IT Education 59