On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
6/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Judicial Authority ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
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
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
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
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
2/5/2025
/ 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
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
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
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
7/12/2024
/ Digital Health ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Life Sciences ,
Medicaid ,
Medical Reimbursement ,
Mental Health ,
Proposed Legislation ,
Regulatory Requirements ,
Rulemaking Process ,
State and Local Government ,
Telehealth ,
Telemedicine
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
Cannabis Products ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology