News & Analysis as of

Labeling Proposed Rules

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

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On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Wiley Rein LLP

FCC Kicks Off Voluntary IoT Security Label Program With Big NPRM

Wiley Rein LLP on

In a new Notice of Proposed Rulemaking (NPRM), the Federal Communications Commission (FCC) imposes a short comment deadline for a complex new cybersecurity labeling regime for Internet of Things (IoT) devices. The NPRM also...more

Troutman Pepper

FDA Proposes New Rules for Prescription Drug Labeling

Troutman Pepper on

On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

ArentFox Schiff

Modernization of Cosmetics Regulation Act of 2022

ArentFox Schiff on

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more

Hogan Lovells

Modernization of U.S. cosmetics regulation will be phased in over time - A detailed overview and preliminary analysis of the new...

Hogan Lovells on

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more

Dechert LLP

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

Dechert LLP on

In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

Mitchell, Williams, Selig, Gates & Woodyard,...

U.S. Environmental Protection Agency Proposed Rule Addressing E15 Motor Fuels: Energy Marketers of America Comments

The Energy Marketers of America (“EMA”) submitted April 19th comments on the United States Environmental Protection Agency (“EPA”) proposed rule for E15 Fuel Dispenser Labeling and Compatibility with Underground Storage...more

Bradley Arant Boult Cummings LLP

Update on Medical Marijuana in Mississippi: Proposed Rules on Advertising, Marketing, Tracking & Labeling

Earlier this week, the Mississippi Department of Health (MSDH) published a second set of proposed rules and regulations, which include Subpart 3 (Advertising and Marketing) and Subpart 4 (Tracking and Labeling). The MSDH...more

Jackson Lewis P.C.

Manufacturers Should Prepare For OSHA’s New And Altered Proposed Hazard Communication Requirements

Jackson Lewis P.C. on

Manufacturers, suppliers, distributors, and importers have often struggled with communicating product hazards to downstream employees and users, due to complex hazard communication requirements in international standards, as...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Underground Storage Tanks/Fuel Dispenser Labeling: U.S. Environmental Protection Agency Proposed Rule Addressing E15

The United States Environmental Protection Agency (“EPA”) published a January 19th Federal Register Notice proposing modifications to the Clean Air Act (“CAA”) and Resource Conservation and Recovery Act (“RCRA”) relating to...more

McDermott Will & Emery

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

McDermott Will & Emery on

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more

Morrison & Foerster LLP - Class Dismissed

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

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