[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
#WorkforceWednesday: OSHA ETS Coming Soon, OSHA Cracks Down on States, and EEOC Updates Guidance - Employment Law This Week®
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Subro Sense Podcast - Unpacking Product Claims Against Amazon
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Taking Notice of Notice Letters
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more
Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
Government investigations are an ever-present reality for companies operating in FDA-regulated industries. Whether you're in pharmaceuticals, medical devices, biologics, laboratories, food, cosmetics, veterinary, or cannabis,...more
There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come to Our Attention” Letter. Any...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
42 state attorneys general joined forces in a bipartisan National Association of Attorneys General (NAAG) letter to Congress, backing the United States Surgeon General’s recent call for Congress to require a surgeon general’s...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on July 16, 2024, to five companies for illegally selling and introducing into the market copycat food products...more
IN THE NEWS AND LATEST UPDATES - Get these and other stories in real time when you subscribe to the Ad Law Access blog here or visit the Advertising and Privacy Law Resource Center here....more
The FTC’s Warning Letters - Earlier this month, the Federal Trade Commission (FTC) sent eight companies warning letters regarding their warranty practices, alerting them that certain restrictive warranty language may violate...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
The FTC and the FDA have sent cease-and-desist letters to five companies alleging that their marketing of edible products containing Delta-8 tetrahydrocannabinol (THC) violates Section 5 of the FTC Act because the packaging...more
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more
The FTC has issued warning letters to eight companies, accusing them of possibly imposing restrictions on third-party servicing of products in violation of the Magnusson-Moss Warranty Act (MMWA). The MMWA is a federal...more
The FTC sent warning letters to eight companies informing them that their warranty practices may violate the Magnuson-Moss Warranty Act (MMWA) by allegedly restricting consumers’ ability to repair their products....more
The FTC is focused on ensuring that consumers have options when it comes to repairing products. Two years ago, we summarized an FTC workshop, report, Policy Statement, and three settlements on this issue. Last week, the FTC...more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
A recent federal court decision is a victory for Health Insurance Portability and Accountability Act (HIPAA) covered entities using third-party tracking tools on unauthenticated webpages. These are websites available to the...more
On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more
On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of...more