Happy 2024! The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more
2/2/2024
/ Ambulatory Surgery Centers ,
Artificial Intelligence ,
Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
HIPAA Violations ,
Hospitals ,
Information Technology ,
Marijuana ,
Medicare ,
Nursing Homes ,
OCR ,
Patient Privacy Rights ,
Pharmaceutical Patents ,
Popular ,
Price Transparency ,
Private Equity ,
Telehealth
Long-shot bill would also allow states to set own laws, make FDA lead regulator, address impact of War on Drugs, impose excise tax, and create CBD dietary supplement pathway. More than five months after first previewing...more
In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more
2/19/2021
/ Agribusiness ,
Beverage Manufacturers ,
Corporate Officers ,
Criminal Liability ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Evidence ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Park Doctrine ,
Policies and Procedures ,
Public Health ,
Public Safety ,
Responsible Corporate Officer Doctrine ,
Training
In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with Tony Pavel, Senior Food Lawyer and Global Food Law Team Leader at Cargill, a global...more
In this episode, host Kermit Nash, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with fellow FBA Practice co-chair, Jonathan Havens, on the portfolios of the U.S. Food and...more
12/7/2020
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Coronavirus/COVID-19 ,
Farmers ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Hemp ,
Regulatory Agencies ,
Relief Measures ,
USDA
On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that, if finalized, would establish a Medicare coverage pathway to provide Medicare beneficiaries with...more
On August 21, 2020, nearly two years after the passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill), the Drug Enforcement Administration (DEA or the Agency) published an interim final rule that, according to...more
This summer has been a busy one in the cannabis and cannabis-derived products spaces. On Wednesday, July 22, 2020, the U.S. Food and Drug Administration (FDA or the Agency) sent to the White House Office of Management and...more
On April 23, 2020, the U.S. District Court for the District of Maryland granted the U.S. Food and Drug Administration’s (FDA or the Agency) request for an extension of the submission deadline for certain deemed tobacco...more
A new decade is upon us, as are substantial federal and state policy, regulatory, and enforcement developments for the tobacco, cannabis, and food and beverage industries. ...more
On November 25, 2019, the U.S. Food and Drug Administration (FDA or the Agency) announced that it had issued Warning Letters to 15 companies for illegally selling products containing cannabidiol (CBD). ...more
On Wednesday, September 11, 2019, in response to a number of highly-publicized vaping-related deaths and illnesses, the Trump Administration (the Administration) announced its intention to ban most flavored e-cigarette...more
On August 15, 2019, the U.S. Food and Drug Administration (FDA or the Agency) published a court-ordered proposed rule that, if finalized, would mandate graphic health warnings for cigarette packaging and advertisements to...more
On May 2, 2019, the U.S. Patent and Trademark Office (USPTO) issued "Examination Guide 1-19 - Examination of Marks for Cannabis and Cannabis Related Goods and Services after Enactment of the 2018 Farm Bill" (Guidance),...more
Although hemp is now federally legal, as a result of the enactment of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) late last year, the Alcohol and Tobacco Tax and Trade Bureau (TTB) recently declared that...more
On April 2, 2019, outgoing U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., further addressed FDA’s approach to cannabis-containing and cannabis-derived products (e.g., cannabidiol...more
Despite the cold temperatures across much of the country, federal and state food policy, regulations, and enforcement developments have been heating up....more
INTRODUCTION -
The Saul Ewing Arnstein & Lehr, LLP health care practice group includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery...more
2/1/2019
/ Cannabidiol (CBD) oil ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Malpractice ,
Medical Marijuana ,
National Practitioner Data Bank (NPDB) ,
OCR ,
Popular
Agency continues to promote use of "robust performance criteria" and "modern predicate devices" -
On January 22, 2019, the U.S. Food and Drug Administration (FDA or the Agency) detailed in a Final Guidance document the...more
On December 20, 2018, President Trump signed into law the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Among other things, the 2018 Farm Bill removes hemp from the definition of "marihuana" (marijuana) in the...more
On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive...more
In recognition of the increasing prevalence of connected medical devices, and the potential cybersecurity vulnerability of the same, the U.S. Food and Drug Administration (FDA or the Agency) issued on October 18, 2018 a draft...more
The U.S. Drug Enforcement Administration (DEA) is expected to publish in the September 28, 2018 edition of the Federal Register an order scheduling U.S. Food and Drug Administration (FDA or the Agency)-approved drugs that...more
On Sept. 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) announced a series of significant enforcement actions related to the sale and marketing of e-cigarettes to minors. ...more
On June 25, 2018, the U.S. Food and Drug Administration (FDA or the Agency) approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy,...more