On July 1, 2019, the New Jersey Department of Health (NJDOH) issued a new Notice of Request for Applications (Notice), replacing the previous Notice that the NJDOH had issued last month, and announced that it is seeking new...more
On June 3, 2019, the New Jersey Department of Health (NJDOH) issued a much-anticipated Notice of Request for Applications (Notice) and announced that it is seeking new applicants to operate up to 108 new medical marijuana...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, the New Jersey legislature advanced three cannabis-related bills out of committee; the measures now go to the floor of each chamber, and votes could occur as early as December 17, 2018....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
As the number of states authorizing use of cannabis increases for both medical and adult (i.e., recreational) purposes, the ambiguities and issues for employers continue to grow. Regardless of expansion at the state level,...more
As a gubernatorial candidate, Phil Murphy ran on a platform of legalizing marijuana in New Jersey. In just seven months since taking office, now-Governor Murphy has taken a number of actions that resulted in the ballooning of...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
On June 21, 2018, the Trump administration proposed consolidation of the federal food safety functions of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection...more
On June 5, 2018, the U.S. Food and Drug Administration (FDA or the Agency) and the U.S. Department of Agriculture (USDA) announced the alignment of USDA's Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with...more
Food and beverage, drug, medical device, cosmetics, and consumer products companies must navigate a maze of legal and regulatory challenges in order to get and keep their products on the market — from concept, to development,...more
On May 4, 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published in the Federal Register a proposed rule that, if finalized, will provide a mandatory uniform national standard for...more
Earlier today, the Pennsylvania Department of Health (DOH), Office of Medical Marijuana (OMM), which oversees the Commonwealth’s medical marijuana program, initiated phase II of its licensing process. OMM is now accepting...more
In remarks at the National Food Policy Conference (NFPC) in Washington, D.C. on March 29, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., detailed the Agency’s wide-ranging plans...more
Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower...more
2017 was a year in contrasts for the health care delivery system. Congress and President Trump made several attempts to “repeal and replace” the Affordable Care Act. Controversy about marijuana continued as more states...more
2/14/2018
/ Affordable Care Act ,
Cybersecurity ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Individual Mandate ,
Marijuana ,
Medical Marijuana ,
Medicare Advantage ,
OCR ,
PHI ,
Popular ,
Telehealth ,
Trump Administration