Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Key Takeaways : On Feb. 6, 2026, FDA announced that it would take action to restrict access to GLP-1 ingredients for non-FDA approved compounded drugs....more
Recent developments involving compounded GLP-1 products have renewed questions about compounded drugs as a potential quasi-generic competitor. This LawFlash examines the regulatory limits on drug compounding and highlights...more
Legislative sessions are underway in most states, and some have introduced novel legislation to regulate compounded medications, including those specific to weight loss....more
Congress Probes Chinese Biotech GLP-1 Product Compliance - Although the FDA recently implemented additional safeguards related to imported GLP-1 products, the safety of GLP-1 active pharmaceutical ingredient (“API”)...more
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to manufacturers, as well as online retailers, clinics, telehealth providers, and compounding pharmacies,...more
On October 28, 2025, the Rhode Island Department of Health (“RIDOH”) issued a public notice of a proposed amendment to 216-RICR-40-15-1: “Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors” (the...more
The US Food and Drug Administration (FDA) recently issued warning letters to more than 40 compounding pharmacies, demanding that they cease certain advertising practices for a variety of compounded drug products, including...more
The U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) on Sept. 9, 2025, announced a broad initiative to "rein in misleading direct-to-consumer pharmaceutical advertisements." In...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
On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down...more
GLP-1 receptor agonists (GLP-1s) such as semaglutide, and dual agonists like tirzepatide, are transforming obesity treatment and reshaping the US health care landscape. Originally developed to manage type 2 diabetes, these...more
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...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
Telehealth companies selling compounded drugs are making modest inroads into the market for popular weight loss drugs that Big Pharma spent decades and billions of dollars to develop and bring to market. The compounded...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
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...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
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 March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more