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Regulatory Agenda Food and Drug Administration (FDA)

Troutman Pepper

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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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

Knobbe Martens

FDA and FTC Crack Down on Delta-8 THC Copycat Products

Knobbe Martens on

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Cozen O'Connor

State AGs Redouble Efforts to Snuff Out Flavored Tobacco Products

Cozen O'Connor on

A group of 20 Democratic AGs, led by Massachusetts AG Andrea Campbell, has filed an amicus brief before the U.S. Supreme Court in Food and Drug Administration v. Wages and White Lion Investments, LLC., dba Triton...more

Foley & Lardner LLP

2024 CPSC and FDA Enforcement Trends

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The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more

McDermott+

CMS Releases Final TCET Notice – Implications and Next Steps

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Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more

Foley & Lardner LLP

FDA: The Effects of Loper on the Regulatory Agenda

Foley & Lardner LLP on

The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 6, July 2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....more

Perkins Coie

White House OMB Food Industry Updates (Spring 2024 Unified Agenda)

Perkins Coie on

Pivotal food regulatory updates abound in the recently released Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, announced earlier this month by the White House Office of Management and Budget (OMB). The...more

Cozen O'Connor

The State AG Report – 7.18.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Gasoline Trading Firms to Pay $50 Million to Settle...more

Troutman Pepper

Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

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In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more

ArentFox Schiff

Post-Chevron Health Care Regulations: The Dawn of a New Day

ArentFox Schiff on

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Foley Hoag LLP

States Wade into FDA Regulatory Territory to Address Chemicals in Foods and Personal Care Products

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Increased public health interest in “forever chemicals” is leading to a new, complex regulatory landscape for manufacturers, distributors, and retailers of foods, cosmetics, and other consumer products. As FDA and other...more

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Foley & Lardner LLP

Some Judges Have — Naturally — Grown Skeptical of False Advertising Class Actions Challenging “Natural” Labels

Foley & Lardner LLP on

Among recent trends in consumer product false advertising class actions has been the rise in cases alleging false advertising for products touting ingredients as “all natural” or “100% natural.” These lawsuits often point to...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+

McDermottPlus Check-Up: May 3, 2024

McDermott+ on

House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more

McDermott Will & Emery

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

Jones Day

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

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The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

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During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...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

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

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