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
5/28/2025
/ Appeals ,
Contract Disputes ,
Contract Terms ,
Drug Pricing ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
State and Local Government
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
5/22/2025
/ Appeals ,
Contract Disputes ,
Covered Entities ,
Drug Pricing ,
Government Agencies ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Preliminary Injunctions ,
Section 340B ,
State and Local Government
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
4/17/2025
/ Appeals ,
Healthcare ,
Hospitals ,
HRSA ,
Litigation Strategies ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
State and Local Government
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
3/19/2025
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Government Agencies ,
Healthcare ,
HRSA ,
Litigation Strategies ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Rebates ,
Regulatory Reform ,
Regulatory Requirements ,
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
3/13/2025
/ Audits ,
Healthcare ,
HRSA ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Payment Reform ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Requirements ,
Section 340B
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...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
3/5/2025
/ Contract Terms ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Healthcare Fraud ,
HRSA ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Pharmacies ,
Rebates ,
Reimbursements ,
Section 340B ,
Technology
On February 6, 2025, the Illinois state legislature introduced Senate Bill (SB) 1998, aiming to implement an additional layer of scrutiny to covered transactions that are financed by private equity groups or hedge funds. The...more
3/5/2025
/ Acquisitions ,
Antitrust Division ,
Antitrust Provisions ,
Consent ,
Healthcare ,
Healthcare Facilities ,
Illinois ,
Mergers ,
Private Equity ,
Regulatory Requirements ,
State and Local Government ,
State Attorneys General
On January 21, 2025, the Washington state legislature introduced Senate Bill (SB) 5387, aiming to codify a restrictive state prohibition on the corporate practice of healthcare, commonly referred to as a corporate practice of...more
3/3/2025
/ Compliance ,
Corporate Practice of Medicine ,
Enforcement Actions ,
Health Care Providers ,
Healthcare ,
Legislative Agendas ,
New Legislation ,
Regulatory Agenda ,
Regulatory Requirements ,
State Legislatures ,
Telemedicine ,
Washington
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
2/27/2025
/ Appeals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...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 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