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No Password Required: A Senior Product Manager at GitLab With an Instagram Alter Ego That Puts Her in Privacy Superhero Territory
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More CBD Certainty: Clearing Confusion over Hemp in New York State
Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A report arguing for raising taxes on alcohol and sugar-sweetened beverages, a law requiring labels to disclose if an animal was harmed during production, a lawsuit calling grain alcohol "inherently dangerous," and more. It...more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more
From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention issued warnings to the public regarding the potential health risks of using Delta-8 THC products on September 14, 2021...more
On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more
The Federal Trade Commission (FTC), in its mission to protect consumers from deceptive and unfair commercial practices, has been particularly vigilant during the COVID-19 pandemic because of an expected increase in outright...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
You’ve created a great product and built a valued brand. You’ve devoted countless hours to building relationships with key distributors and retailers, designing attractive packaging, and forging a social media presence. But...more
On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more
What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more
A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more
As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more