News & Analysis as of

Food and Drug Administration (FDA) Regulatory Agenda Compliance

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

Foley & Lardner LLP

Telehealth Companies and Social Media Influencers May Face New FDA Laws

Foley & Lardner LLP on

On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

ArentFox Schiff on

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

Gardner Law on

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - November/December 2024

Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Bradley Arant Boult Cummings LLP

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

Wiley Rein LLP on

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

McDermott Will & Schulte

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more

Health Care Compliance Association (HCCA)

After GAO Report, OHRP Asks SACHRP to Tackle Elusive Goal: Define, Measure IRB Effectiveness

After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more

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