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
FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more
While the modalities of advertising may change, advertising’s core tenant of claims substantiation remains an unwavering constant. As such, legal and regulatory professionals in marketing and advertising set their calendars...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service...more
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more
We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
The first quarter of 2023 witnessed significant litigation and regulatory developments that will undoubtedly affect members of the chain of commerce in the food and beverage industry. Specifically, putative class actions...more
Two recent developments at the federal level are intended to encourage more food donations. First, President Biden signed the Food Donation Improvement Act (FDIA), which expands Good Samaritan liability protections. Second,...more
In the pilot episode of NBC’s Parks and Recreation, Leslie Knope, deputy director of the Pawnee Parks and Recreation Department, promises her constituents she will fill in “the pit” that has become a hazard to her community...more
The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more
Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. Psilocybin is a Schedule I psychoactive substance that is illegal at the federal level. Notwithstanding this federal...more
On January 20, 2023, the US Food and Drug Administration’s (FDA) final rule on food traceability will take effect. Regulated entities will have a three-year compliance period, with a current compliance date of January 20,...more
The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
Join us on December 14 for a webinar providing a 2022 FDA year-in-review, with a crystal ball look into 2023. Venable Partners Claudia Lewis and Todd Harrison will discuss myriad topics, including a recap of major issues...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
President Biden has revealed the next areas of focus in his effort to protect the United States’ technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy....more
Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more
On May 19, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit issued an opinion holding that Delta-8 THC products are legal at the federal level and eligible for intellectual property protection...more