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Regulatory Standards Labeling

Foley & Lardner LLP

What Every Multinational Company Should Know About ...“Made in USA” Labeling Requirements

Foley & Lardner LLP on

Many Americans value domestically made goods. A “Made in USA” label can hold special meaning for these consumers, as it serves as a symbol of patriotism, a sign of quality craftsmanship, and a show of solidarity with local...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Jones Day

Environmental Labels, Greenwashing, and Ecocide Tackled by France's New Climate Law

Jones Day on

On August 22, 2021, the French Parliament adopted the Climate and Resilience Law ("2021 Climate Law"). In aiming to accelerate the transition to a carbon-neutral and more resilient society, the 2021 Climate Law imposes...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

Faegre Drinker Biddle & Reath LLP

Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling...more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

Hogan Lovells on

On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

King & Spalding

Design, Designation and Regulatory: Structuring Considerations and Regulatory Due Diligence in EU Food and Beverage Transactions

King & Spalding on

When structuring and assessing transactions in the food and beverage sector in a European context, a purchaser must consider and evaluate several EU-specific requirements in order to ensure a successful transaction with...more

Hogan Lovells

Total Brand Care Q&A – Product labeling and packaging in Europe

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Hogan Lovells Total Brand Care is our firmwide holistic approach to creating, commercializing and protecting our clients’ most valuable asset – their brands. Creative product labeling and packaging can help promote and add...more

Hogan Lovells

The opportunities and challenges associated with product labeling and packaging in Europe: Total brand care

Hogan Lovells on

From bright and glossy, to refined and elegant, product labeling and packaging convey information, messaging, and claims about a brand. At the same time the labeling and packaging must also include mandatory information,...more

Kilpatrick

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

Kilpatrick on

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug...more

Hogan Lovells

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

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On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Kelley Drye & Warren LLP

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

Morgan Lewis

Making a “Made in the USA” Claim Requires a Reading of Federal and State Law

Morgan Lewis on

Given the rise in false advertising claims, manufacturers and retailers that wish to label or advertise their goods as being “Made in the USA” must be aware of federal and state laws that place certain requirements on the...more

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