[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
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
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
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
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
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
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more
“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more
As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids...more
On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into...more
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug...more