What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
MLM Defense: FTC Earnings Claims and Nonsolicitation Clauses
Supply Chain Disruptions with Special Guest Chris Mills, CEO of Lion Brand Yarn
Law Brief®: Mark Rosenberg and Richard Schoenstein Discuss Online Distribution Leakage
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
Texas House Passes Pandemic Liability Protection Act
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
From Farm to Shelf – COVID’s Impact on Global Supply Chains
Protecting Trade Secrets When Facing Lawsuits or Alternative Dispute Resolution Procedures
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
RCG Webinar | Where's the Beef?
Lowndes Client Corner Podcast Episode 1 - DraftLine Technologies, The Business of Beer
Protecting Trade Secrets During Business Collaboration
Kentucky AG Russell Coleman filed a lawsuit against the Kroger Company and affiliated entities alleging that it contributed to the opioid epidemic in the state in its role as a drug distributor and operator of retail...more
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps...more
We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more
In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more
In a recent decision, the Court of Appeals for the Third Circuit closed the door on triangular setoffs, ruling that the mutuality requirement under Section 553 of the Bankruptcy Code must be strictly construed and requires...more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an...more
This post is an update from our earlier blog post, available here, on the bellwether federal opioids trial in the Northern District of Ohio. Just hours prior to the start of the trial in a consolidated case involving two...more
FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise...more
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
Fresenius Medical came close to earning a declination under the FCPA Corporate Enforcement Policy. Unfortunately, Fresenius’ effort fell short — but it came close. Fresenius Medical operates more than 3700 dialysis clinics...more
The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that "will allow DEA-registered...more
State of Delaware ex rel. Jennings v. Purdue Pharma L.P., et al., C.A. No. N18C-01-223 MMJ CCLD (Del. Super. Feb. 4, 2019). In January 2018, Delaware’s Attorney General filed an action against certain opioid makers and...more
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
Massachusetts Supreme Judicial Court Recognizes Claim Against Brand-Name Drug Manufacturer By Generic Drug User Where Failure To Warn Is Reckless - In Rafferty v. Merck & Co., 479 Mass. 141 (2018), plaintiff alleged...more
On March 20, 2018, the Federal Court of Appeal (FCA) issued public reasons for judgment dismissing Eli Lilly Canada Inc. (Lilly)’s appeal of a Federal Court decision awarding more than $70 million to Teva Canada Limited...more
Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more