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Jan 22, 2025 | 
jdsupra.com | Shoshana Golden |Dan Jasnow |Wayne Matelski
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Jan 21, 2025 | 
afslaw.com | Dan Jasnow |Wayne Matelski |Shoshana Golden
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Jan 6, 2025 | 
natlawreview.com | Shoshana Golden
Skip to main content January 06, 2025 Volume XV, Number 6 Legal Analysis. Expertly Written. Quickly Found.
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Jan 6, 2025 | 
afslaw.com | Shoshana Golden |Emily Leongini
On As you know, MoCRA was passed just over two years ago on December 29, 2022, and imposed extensive new requirements related to cosmetic products. We have covered those provisions at length across various alerts, which we have hyperlinked below. Now that it is officially 2025, we wanted to recap which MoCRA requirements have gone into effect and which are still yet to come.
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Nov 22, 2024 | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.
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Nov 21, 2024 | 
afslaw.com | Stephanie Trunk |Shoshana Golden
Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here. The PFS final rule can be found here, with the companion CMS fact sheet available here. Both rules are effective January 1, 2025. Below is an overview of the relevant provisions for pharmaceutical manufacturers and the pharma community.
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Sep 4, 2024 | 
jdsupra.com | Shoshana Golden |Douglas Grimm |Gayland Hethcoat II
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies. Three years later, the “340B Saga” continues. Following the filing of new cases and developments in others, we are back with another update.
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Sep 3, 2024 | 
afslaw.com | Douglas Grimm |Stephanie Trunk |Shoshana Golden
On Drug Manufacturers Prevail on Appeal in Challenges to HRSA’s Efforts to Limit Contract Pharmacy ConditionsThe 340B Program provides certain health care organizations, referred to as “covered entities,” with access to discounted outpatient drugs from manufacturers. Many covered entities, lacking their own pharmacies, enter into agreements with outside pharmacies, or “contract pharmacies,” to dispense discounted drugs to patients.
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Jul 18, 2024 | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. The unpublished HOPPS proposed rule can be found here (published version scheduled to be issued on July 22), with a high level summary in the CMS fact sheet available here. Comments to the HOPPS proposed rule are due September 9.
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Jul 17, 2024 | 
afslaw.com | Stephanie Trunk |Shoshana Golden
The unpublished HOPPS proposed rule can be found here (published version scheduled to be issued on July 22), with a high level summary in the CMS fact sheet available here. Comments to the HOPPS proposed rule are due September 9. The unpublished PFS proposed rule can be found here (published version scheduled to be issued on July 31), with the companion CMS fact sheet available here. Comments to the PFS proposed rule are also due September 9.
