Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
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
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...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
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more
The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
Antitrust- 10 Attorneys General Sue to Enjoin Merger of Major Wireless Phone Companies- 10 AGs, led by New York AG Letitia James and California AG Xavier Becerra, filed a lawsuit to enjoin T-Mobile US, Inc. and its parent...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more