Daily Compliance News: September 17, 2025, The Talking Bad Edition
5 Key Takeaways | The U.S. Investment in Clean Energy and the Potential for Supply Chain Snags
WorldSmart: The Future of Business and Supply Chain Challenges During the Age of COVID
RCG Webinar | Where's the Beef?
Geopolitics and supply chain risk have emerged as top concerns for Chief Legal Officers. These factors are shaping strategic plans and competitive advantage as well as day-to-day operations. ...more
The Background: After more than two years of negotiation following the European Commission's April 2023 proposal to overhaul the EU pharmaceutical framework, the EU institutions have finally converged on a package. The...more
The nation recently slid past Black Friday and now is bounding through the busy holiday retail season. Retailers should be preparing for a unique challenge that awaits in the New Year. The federal government shifted U.S....more
With the signing of New York Senate Bill S4153A by Gov. Kathy Hochul, New York state has enacted a sweeping requirement for "retail establishments" and "food stores" to accept cash payments for in-person transactions. The...more
Your supply chain contract is up for renewal—either automatically or because you’ve been given a renewal notice or not received a termination notice. Typically, without much thought, many manufacturers, suppliers and their...more
The Food and Drug Administration (FDA) recently declared an end to the shortage of semaglutide (Ozempic and Wegovy) and tirzepatide (Mounjaro and Zepbound), categorized broadly as GLP-1 weight loss medications. Both products...more
Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the Daily Compliance News....more
The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical...more
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
This monthly report outlines key developments in China’s antitrust sector for June. The following events merit special attention: SAMR Seeks Comments on Provisions for Curbing Acts of Abusing Administrative Power to Eliminate...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...more
Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more
Ozempic's meteoric rise has reshaped the landscape of healthcare, retail, and consumer behavior. Its initial popularity as a weight loss medication has sparked a broader conversation around health, wellness, and body image....more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On November 20, 2024, Health Canada posted Drug shortages in Canada: Fiscal year 2023 to 2024 in review. The review includes an overview of drug shortages, how Health Canada addresses shortages and the number of drug...more
Paradoxically, the world of the mid 2020s is a world in which countries otherwise rich in energy supply nonetheless have been having trouble keeping the lights on, both undermining their political, societal, and economic...more