In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
10/1/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preamble ,
Proposed Rules ,
Repeal ,
Totality of Circumstances Test
As the world’s health care facilities grapple with the devastating and unexpected operational struggles brought by COVID-19, nursing homes and long-term care facilities face the added challenge of protecting their residents...more
Congress has been working for months to pass legislation protecting patients from surprise medical bills that arise when insured patients unknowingly receive out-of-network (OON) care, usually when receiving emergency medical...more
2/26/2020
/ CBO Report ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Inpatient Billing ,
Legislative Agendas ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
Physicians ,
Proposed Legislation ,
Surprise Medical Bills
Hemp production is a large and growing industry in the United States. Even before Congress’ passage of the Agriculture Improvement Act of 2018 (better known as the 2018 Farm Bill), the Hemp Business Journal estimated that...more
11/11/2019
/ Cannabidiol (CBD) oil ,
Decriminalization of Marijuana ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Related Businesses ,
Regulatory Oversight ,
USDA
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
5/13/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Free Speech ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Regulatory Oversight ,
Statutory Authority ,
Television Commercials ,
Trump Administration
The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more
2/8/2019
/ Advertising ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Claims Act (FCA) ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors ,
Trump Administration
On June 8, Pennsylvania Governor Tom Wolf signed into law the first major overhaul of the Commonwealth’s Liquor Code since the end of Prohibition. Wolf heralded the measure as enhancing customer convenience while providing...more
6/10/2016
/ Beer ,
Business Licenses ,
Casinos ,
Hotels ,
Licensing Rules ,
Liquor ,
New Legislation ,
Operational Permits ,
Restaurant Industry ,
Retail Licenses ,
Shipping ,
Wine & Alcohol