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Regulatory Agenda Regulatory Oversight Food and Drug Administration (FDA)

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

Gardner Law on

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

Venable LLP on

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

Troutman Pepper Locke

Opportunities for the Trump Administration to Step Up Enforcement Against Unauthorized ENDS

Troutman Pepper Locke on

Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more

DLA Piper

Food and Beverage News and Trends - December 2024

DLA Piper on

On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National...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

Troutman Pepper Locke

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

Troutman Pepper Locke on

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

McDermott Will & Schulte

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more

Foley & Lardner LLP

FDA Continues to Take Stance That it Will Not Issue CBD Rules

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...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

Troutman Pepper Locke

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper Locke on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Shook, Hardy & Bacon L.L.P.

Proposed FDA Restructuring Would Move Cosmetics under Office of Chief Scientist

A proposed U.S. Food and Drug Administration (FDA) restructuring plan seeks to move cosmetics regulation and color certification out of the Center for Food Safety and Applied Nutrition and into the Office of Chief Scientist...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.

FDA Commissioner Announces Redesign of Human Foods Program

U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Epstein Becker & Green

Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more

Akin Gump Strauss Hauer & Feld LLP

FDA Harshes the CBD Buzz; is it High Time for Congress to Step In?

The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more

Foley Hoag LLP - Cannabis and the Law

Cannabis Health Claims Face Increased Scrutiny As More States Roll Out Recreational Dispensaries

As the number of adult-use states continues to grow—with New York, New Jersey, Connecticut, Rhode Island, and Vermont recently joining the ranks—the scrutiny of cannabis-related advertising has grown with it...more

Hogan Lovells

OMB releases Fall 2022 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

Hogan Lovells

FDA issues draft guidance on remote regulatory assessments

Hogan Lovells on

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

Dickinson Wright

[Webinar] The Regulatory Landscape for Cannabis Products in the U.S. and Canada - Is the Grass Greener on the Other Side? -...

Dickinson Wright on

The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....more

Hogan Lovells

OMB releases Spring 2021 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more

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