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
Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more
At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more
The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more
It remains unclear the extent to which the order will impact agencies like FDA. On February 11, 2025, as part of an ongoing effort to reduce the size of the federal workforce, President Trump issued an executive order titled...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more
Shortly after being sworn in on January 20, President Trump issued several actions, including issuing executive orders and instructions to agencies, that will affect the regulatory environment facing the food and agriculture...more
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...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
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
Amidst increasing positive COVID-19 cases in Puerto Rico, Governor Pedro R. Pierluisi has issued an executive order requiring those working in healthcare and education settings to get vaccinated and boosted. Covered...more
New York City Mayor Bill de Blasio issued an Executive Order on August 16, 2021 setting forth the requirements of the “Key to NYC” vaccine mandate that was announced earlier this month for indoor dining, gyms and...more
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more
Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more