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
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
In a development that is expected to complicate many litigation challenges alleging that the presence of low levels of microplastics in food is inherently unsafe, officials from the US Food and Drug Administration (FDA or...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
Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more
The Department of Justice (DOJ) published a Notice of Proposed Rulemaking to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA) in the Federal Register on May 21, 2024. If the...more
As the age of tobacco-based nicotine products shrinks in the rearview mirror, it comes as no surprise that consumers, young and old, are increasingly being drawn to its modern equivalent: e-cigarettes, also known as vapes....more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis)...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more
We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual...more
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of...more