Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Podcast - FTC's Approach to Made in the USA Claims
Proposition 65 – Changes That Will Impact the Cannabis Sector
PODCAST: Williams Mullen's Trending Now: An IP Podcast - False and Misleading Advertising, Label Review
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely
Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
Depo-Provera, a birth control injection containing the hormone medroxyprogesterone acetate, has been widely used for decades as a convenient contraceptive option. For many women, the Depo shot offered an alternative to daily...more
Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the first quarter of 2025. In this edition, two UK actions fail to clear a low bar, a movie isn’t a video, and spam isn’t...more
Women across the country are taking legal action against Pfizer, the manufacturer of Depo-Provera, alleging that the company failed to warn about the risks of developing meningiomas — generally non-cancerous but potentially...more
On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
In 2022, over 500 plaintiffs filed a case alleging that Merck Sharp & Dohme Corp., a drug manufacturing company, failed to provide adequate warnings that one of their drugs increased the risk of atypical femoral fractures....more
On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more
Takeaway: When it comes to mislabeling and related claims, and especially when human safety is not implicated, express preemption under the federal Food, Drug and Cosmetic Act (FDCA) remains a powerful tool in the hands of...more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...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
Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more
Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more
As we continue to assess the ripple effects from the Supreme Court's denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of...more
On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. ...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more
On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more
On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid...more
On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more