Searching Content indexed under Food and Drugs Law by McDermott Will & Emery ordered by Published Date Descending.
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Is Your Software A Medical Device? FDA Issues Six Digital Health Guidance Documents
The FDA recently released six guidance documents as part of the agency's continued focus on updating the regulatory stance on software as a medical device and other digital health products
United States
16 Oct 2019
Safe Banking Act Passes House, Extends Cannabis Safe Harbor Protections
First introduced in 2013, the SAFE Banking Act passed the House 321-103 yesterday. This bill provides safe harbor to banks and financial institutions...
United States
7 Oct 2019
Court Dismisses Challenge To TTB's Rejection Of Health Claims On Vodka
In August, the US District Court for the District of Columbia issued its final decision in Bellion Spirits, LLC v. United States, Civ. No. 17-2538 (JEB).
United States
9 Sep 2019
DOJ Continues Telemedicine Enforcement In Q2 2019
During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine.
United States
29 Aug 2019
TTB Publishes New Nonbeverage Product Formula Form
On August 12, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published its updated Formula and Process for Nonbeverage Product, TTB Form 5154.1.
United States
22 Aug 2019
Cannabis And Hemp Update
The legal status of cannabis (often called "marijuana" in federal and state laws) has evolved at an astonishing pace.
United States
2 Aug 2019
FDA CBD Docket Closed, Agency To Soon Provide Status Report
The Food and Drug Administration (FDA) has increased its efforts to follow through on its commitment to provide guidance to stakeholders on the regulatory landscape for products containing CBD.
United States
30 Jul 2019
Implications Of The Supreme Court's Tennessee Retailers Decision
As virtually everyone in the US alcohol beverage industry knows, last week the US Supreme Court handed down its opinion in Tennessee Wine and Spirits Retailers Assn
United States
16 Jul 2019
TTB Publishes NPRMs To Repeal Standards Of Fill For Wine And Distilled Spirits
On Monday, July 1, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published two eagerly anticipated notices of proposed rulemaking (NPRMs) to largely repeal the standards of fill for wine and distilled spirits containers.
United States
12 Jul 2019
Courts Are Siding With Employees Who Use Medical Marijuana
Marijuana, a Schedule 1 drug under the federal Controlled Substances Act (CSA), is the most commonly detected illicit drug in employment drug testing
United States
3 Jul 2019
24th Annual Wine, Beer & Spirits Law Conference
On September 16–17, CLE International will host the 24rd Annual Wine, Beer & Spirits Law Conference in Charlotte, North Carolina.
United States
25 Jun 2019
Learnings From The FDA Hearing On Cannabis And Cannabis-Derived Compounds
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information
United States
21 Jun 2019
Mississippi Supreme Court Ruling Reinstates Claims Against Anheuser-Busch, Mitchell Distributing
On May 23, the Mississippi Supreme Court published its opinion in the case of Rex Distributing Company v. Anheuser-Busch, LLC, et al.
United States
19 Jun 2019
USDA Issues Opinion On Several Hemp-Related Provisions Of The 2018 Farm Bill
On May 28, 2019, the United States Department of Agriculture (USDA) issued a legal opinion to address questions raised by several hemp-related provisions of the Agricultural Act of 2018,
United States
18 Jun 2019
If The DEA Does Not Quickly Reexamine Marijuana's Classification Under The Controlled Substance Act, The Second Circuit Might
Plaintiffs claim that marijuana has extended their lives, cured seizures and made pain manageable.
United States
13 Jun 2019
Winds Of Change Blowing For Craft Brewers
For those who follow developments in the law and craft brewing with equal passion, every year has its share of substantial issues. This year has been no exception, with a pending Supreme Court case; a substantial upswing in federal trade practice enforcement activity;
United States
12 Jun 2019
TTB Spring 2019 Updates To Semi-Annual Regulatory Agenda
The spring edition of the federal government's semi-annual Unified Agenda of Federal Regulatory and Deregulatory Actions (Regulatory Agenda) has been published.
United States
10 Jun 2019
CDC And SAMHSA To Hold Summer Meetings For Public Health And Marijuana
The Centers for Disease Control (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA) announced meetings to be held this summer related to public health and marijuana
United States
6 Jun 2019
Arbitration Clause In Beer Distribution Agreement Enforced By The Virginia ABC
On May 7, 2019, the Virginia Department of Alcoholic Beverage Control (VABC) published a decision confirming the enforceability of arbitration clauses in distribution agreements ...
United States
4 Jun 2019
First Of Its Kind: Drug Wholesaler Accepts DPA And Two Executives Face Criminal Charges In SDNY For Illegal Distribution Of Opioids
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC),
United States
22 May 2019
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