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Wiley Rein LLP

FDA’s Proposed Ranking Tool Gives Public Opinion a Seat at the Food Safety Table

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With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more

Blank Rome LLP

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

Blank Rome LLP on

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

Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

Wilson Sonsini Goodrich & Rosati

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

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

DLA Piper

Food and Beverage News and Trends - February 2025

DLA Piper on

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

Eversheds Sutherland (US) LLP

Beyond the binary: How NIST is shaping the policies and practices of AI innovation and risk management

On September 24th and 25th, the National Institute of Standards and Technology (NIST) convened a symposium to generate new insights about the next steps needed to unleash AI innovations that will enable trust in this...more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

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

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - March 2023

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Update on Human Foods Program Restructuring - The U.S. Food and Drug Administration (FDA) has issued a news release with an update on the restructuring of its Human Foods...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - January 2023

LEGISLATION, REGULATIONS & STANDARDS - Omnibus Spending Bill Includes Congressional Notes to FDA - President Biden has signed a spending bill that includes additional funding for the U.S. Food and Drug Administration (FDA)...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

Morgan Lewis

Digital Health Trends to Watch in 2022

Morgan Lewis on

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

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

Bass, Berry & Sims PLC on

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

Epstein Becker & Green on

Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

Bodman

The ABCs of CBD and Hemp: A Primer

Bodman on

Hemp and marijuana both come from the cannabis sativa plant but as a result of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), cannabis sativa with a THC content of less than 0.3% was removed from the federal...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

McDermott Will & Schulte

FDA Issues Artificial Intelligence/Machine Learning Action Plan

On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2020

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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

Sheppard Mullin Richter & Hampton LLP

FDA Year in Review: A Shifting Regulatory Landscape

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

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells on

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

Patrick Malone & Associates P.C. | DC Injury...

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

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

Akin Gump Strauss Hauer & Feld LLP

Podcast: CBD, THC, FDA – What You Need to Know About Cannabis and Its Regulation

In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD. Among the topics...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

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

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