Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On January 10, 2025, the Oregon Legislative Counsel introduced Senate Bill (SB) 951, aiming to modernize Oregon’s corporate practice of medicine (CPOM) doctrine. If enacted, SB 951would prohibit management services...more
2/17/2025
/ Corporate Governance ,
Healthcare ,
Legislative Agendas ,
New Legislation ,
Non-Disclosure Agreement ,
Oregon ,
Physicians ,
Proposed Legislation ,
Regulatory Requirements ,
Restrictive Covenants ,
State and Local Government ,
State Legislatures ,
Telehealth
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/13/2025
/ Audits ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
FOIA ,
Health Care Providers ,
Healthcare ,
HRSA ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/5/2025
/ Class Action ,
Enforcement Actions ,
FOIA ,
Health Care Providers ,
Healthcare ,
HRSA ,
Medicare ,
Medicare Advantage ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Section 340B
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies.
Under the new...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
1/16/2025
/ Appeals ,
Breach of Contract ,
Contract Terms ,
Health Care Providers ,
Healthcare ,
Litigation Strategies ,
Medicare ,
Medicare Payment Reform ,
Prescription Drugs ,
Section 340B ,
State and Local Government
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more
12/26/2024
/ Comment Period ,
Cosmetics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Listing Rules ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Identifiers ,
Product Labels ,
Product Packaging ,
Registration Requirement
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more
The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more
12/6/2024
/ Biosimilars ,
Corporate Governance ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Pharmaceutical Industry ,
Presidential Elections ,
Regulatory Agenda ,
Stakeholder Engagement ,
Transparency ,
Trump Administration ,
Vaccinations
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
10/10/2024
/ Drug Compounding ,
Food and Drug Administration (FDA) ,
Goods or Services ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Supply Shortages
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
8/13/2024
/ Digital Health ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Physicians ,
Proposed Legislation ,
Regulatory Agenda ,
Rulemaking Process ,
State and Local Government ,
Technology Sector ,
Telehealth ,
Telemedicine
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
7/30/2024
/ Digital Health ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospice ,
Legislative Agendas ,
Life Sciences ,
Proposed Legislation ,
Regulatory Requirements ,
Regulatory Standards ,
Rulemaking Process ,
State and Local Government ,
Telehealth ,
Telemedicine
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
7/17/2024
/ Digital Health ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Regulatory Requirements ,
Reimbursements ,
Rulemaking Process ,
State and Local Government ,
Telehealth ,
Telemedicine