Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more
This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more
Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
Type I Diabetes is the most common type of diabetes in children, impacting about 1 in 400 children in the US according to the American Diabetes Association. Children diagnosed with Type 1 diabetes require lifelong daily...more