Popular, Regulatory Oversight, Pharmaceutical Industry

Trump Administration Executive Order Tracker - updated 8.18.25

McDermott+ on 8/20/2025

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Federal and State Agencies Ramp Up Scrutiny of the GLP-1 Drug Market

Blank Rome LLP on 8/12/2025

Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on 5/27/2025

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

Wilson Sonsini Goodrich & Rosati on 3/13/2025

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Recent Healthcare-Related Artificial Intelligence Developments

Sheppard Mullin Richter & Hampton LLP on 2/27/2024

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

What’s Next for AI? Six Areas to Watch in 2024

Goodwin on 1/17/2024

Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on 11/7/2023

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Digital Health Trends to Watch in 2022

Morgan Lewis on 2/25/2022

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Vital Signs: Digital Health Law Update | Winter 2020

Jones Day on 1/17/2020

NOTE FROM THE EDITORS - Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital...more

FDA Year in Review: A Shifting Regulatory Landscape

Sheppard Mullin Richter & Hampton LLP on 1/8/2020

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more

Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells on 10/10/2019

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Patrick Malone & Associates P.C. | DC Injury... on 10/10/2019

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more

Digital Health Report - Summer 2019

Wilson Sonsini Goodrich & Rosati on 6/24/2019

Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more

FDA’s dubious oversight of heart devices: hidden complaints and shaky tests

Patrick Malone & Associates P.C. | DC Injury... on 5/31/2019

Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the...more

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on 4/11/2019

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Brexit: the impact on supplementary protection certificates (SPCs)

Hogan Lovells on 3/18/2019

On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or...more

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What...

Hogan Lovells on 10/22/2018

On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more

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