Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
With DEA’s marijuana rescheduling hearing now delayed indefinitely, the most promising prospect for meaningful cannabis reform may lie in the hands of Congress. Seemingly undeterred by the strong headwinds that have scuttled...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as...more
The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
News Briefs - Federal Judge Rejects Attempt to Stop Nursing Home Staffing Rule - A federal judge has rejected a bid by 20 Republican state attorneys general to block enforcement of a new rule adopted by the outgoing Biden...more
On January 13, the chief administrative law judge of the US Drug Enforcement Administration (DEA), John Mulrooney, postponed the highly anticipated hearing on the rescheduling of cannabis under the Controlled Substances Act...more
Welcome to Nutter's Beverage Breakdown, a periodic legal update on developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. We look forward to sharing our insights...more
The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more
A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more
Republished with Permission In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more
Historic DEA marijuana rescheduling hearing opens, paused until mid-January - Historic hearings to reconsider marijuana's federal status will start mid-January, as announced by U.S. DEA Judge John Mulrooney II. The focus...more
No, it’s not (just) a cruel play on words. Last week, the Drug Enforcement Administration announced a much-anticipated public hearing on the proposal to reschedule marijuana from early December until the first quarter of...more
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for...more
In perhaps his most controversial cabinet appointment yet, earlier today, President-elect Trump said he would nominate Florida Rep. Matt Gaetz as U.S. Attorney General. Although Gaetz’s nomination was met with skepticism by...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
In a non-public letter sent earlier last week, the US Department of Health and Human Services (HHS) recommended to the US Drug Enforcement Administration (DEA) that marijuana be re-classified under the Controlled Substances...more
The legal landscape relating to the permissible use of medical marijuana in the United States is evolving rapidly, presenting employers with a complex legal environment to navigate, with states taking varying stances on the...more
In May, President Biden announced the Drug Enforcement Administration (DEA)’s proposed rule reclassifying marijuana from a Schedule I drug to a Schedule III drug under the Controlled Substances Act (CSA)....more
Even with the expected rescheduling of cannabis from a Schedule I drug to a Schedule III drug, it will take more for it to be eligible for interstate commerce. Marijuana would remain subject to provisions of the Food,...more
On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more
The federal government has started to reclassify cannabis. When, and if, that reclassification is finalized, licensed cannabis businesses should see dramatically higher after-tax income and access to services from credit card...more