Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
Nonalcoholic beverages infused with delta-9 tetrahydrocannabinol (THC) derived from hemp (aka intoxicating hemp beverages) are becoming increasingly popular for consumers looking for an alternative to alcohol....more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
Many states with cannabis legalization have manufacturer and dispensary licenses that make and sell cannabis-infused beverages and even cannabis-infused drink mixes. What you don’t usually see is a major liquor retailer...more
Tetrahydrocannabinolic acid (THCA) is one of the most misunderstood and controversial cannabinoids in the Cannabis sativa (cannabis) plant. While booming in popularity, THCA is also a high-risk cannabinoid from a legal...more
Last week in a small hearing room in a House office building, the House Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing titled “Hemp in the Modern World: The Years long Wait for...more
After the 2018 Farm Bill legalized hemp at the federal level, Texas was one of the last states to legalize it at the state level. Governor Abbot passed House Bill 1325 in 2019, legalizing hemp cultivation as well as the...more
The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8). In May 2022, the U.S. Food and Drug...more
The FDA held a “stakeholders” call on May 25 to present information on how it reached its present stance concerning CBD and to answer a few questions. FDA’s presentation included its assessment of survey data concluding that...more
Welcome to the latest installment of the Editors’ Roundtable, in which our editors – Whitt Steineker, Jay Wright, Hunter Robinson, and Slates Veazey – discuss cannabis issues in the news and take a stab at where the cannabis...more
On the heels of a January 2023 statement released by the FDA expressing the need for a new regulatory pathway for cannabidiol products, two CBD-related bills were reintroduced in the House of Representatives on March 17,...more
After rounding out 2022 with a series of warning letters to companies selling products containing cannabidiol (“CBD”) the U.S. Food and Drug Administration (“FDA”) began 2023 by issuing a press release announcing its...more
There is a moment in the movie Wall Street, just before a fresh-faced Charlie Sheen as Bud Fox interviews for a coveted position with a peak-of-his-fame Michael Douglas playing the iconic Gordon Gecko, where Sheen looks in...more
FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more
The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more
The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more
FDA Rejects Citizen Petitions, Declines To Regulate CBD as a Dietary Supplement - The U.S. Food and Drug Administration (FDA) announced its conclusion that a new regulatory pathway for cannabidiol (CBD) is needed on...more
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more
FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a...more
Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more
On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC)...more
This month marks the 20th anniversary of Shook, Hardy & Bacon’s Food and Beverage Litigation and Regulatory Update (FBLU). Since publishing its first edition in October 2002, Shook has continuously covered the legal,...more
It is hard to believe that almost five years have passed since the 2018 Farm Bill (or The Agricultural Improvement Act of 2018, if you want to be formal) legalized industrial hemp and revolutionized an entire industry. Since...more