Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more
Connecticut AG William Tong announced a settlement with Triggered Brand following allegations that the company unlawfully advertised and sold counterfeit GLP-1 weight loss drugs in violation of state consumer protection laws....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
Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more
Connecticut AG William Tong announced enforcement actions against companies that allegedly advertised, distributed, or sold so-called “research grade” versions of GLP-1 weight loss drugs in violation of state consumer...more
On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025....more
Two new class action complaints, both captioned Robins v. Lemme Inc., were filed in in California Superior Court and the Southern District of New York on February 19 and March 9, respectively....more
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more
The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more
1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more
Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more
They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...more
Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more
The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food,...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by...more
LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more
Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a pharmaceutical company committing...more
LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more