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Healthcare › New Guidance › Comment Period

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Sheppard Mullin Richter & Hampton LLP

From Good Reprint Practices to SIUU Communications: What Firms Need to Know

Sheppard Mullin Richter & Hampton LLP on

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Nossaman LLP

CDC Updates Guidance on Opioid Prescriptions

Nossaman LLP on

In a shift from prior policy, the Centers for Disease Control and Prevention (CDC) proposed on February 22, 2022, new guidelines for prescribing opioid painkillers. The new guidance largely avoids figures on dosage strength...more

Perkins Coie

NIST Seeks Comment on Proposals to Identify and Manage Bias in Artificial Intelligence

Perkins Coie on

The National Institute of Standards and Technology (NIST) recently published “A Proposal for Identifying and Managing Bias in Artificial Intelligence,” a special publication that is part of a series of documents and workshops...more

Katten Muchin Rosenman LLP

New Cybersecurity Guidance for the Health Care Industry (and Last Call for HIPAA Rule Comments)

Katten Muchin Rosenman LLP on

We discuss below two important updates impacting health care industry clients...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

Proskauer - Employee Benefits & Executive...

New IRS Guidance on 40% Excise Tax Previews Future Regulatory Complexity

Proskauer - Employee Benefits & Executive... on

Although public opposition to the 40% excise tax on high-cost health care is rapidly growing, the IRS continued to develop a regulatory framework for administration of the excise tax through its issuance of Notice 2015-52 on...more

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