News & Analysis as of

Labeling

TTB Releases Results of Annual Sampling Program: Many Common Label Violations Can Easily Be Avoided

Each year the TTB conducts its Alcohol Beverage Sampling Program where it randomly purchases products to assess whether their labels comply with federal regulations and to test whether their contents comply with the...more

RCRA Update: New Hazardous Waste Generator Rule Goes Into Effect in May 2017

EPA’s final Hazardous Waste Generator Improvements Rule (“Rule”), which goes into effect on May 30, 2017, contains approximately 60 revisions to the hazardous waste generator regulatory program. The revisions focus on...more

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

Task Force Report: Branding and Packaging of Cannabis

by Bennett Jones LLP on

In this edition of our series on the Task Force’s final report "A Framework for the Legalization and Regulation of Cannabis in Canada" (the "Report") we explore the Task Force’s recommendations in relation to advertising,...more

Implications of EU Ingredient Labeling Proposal for US Suppliers

by McDermott Will & Emery on

On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and...more

Proposed Regulation in Texas on Name and Address Labeling for Malt Beverages

by McDermott Will & Emery on

Last week, the Texas Alcoholic Beverage Commission (“TABC”) circulated a draft amendment of Texas’ name and address labeling regulation for “malt beverages” (beer). ...more

Blog: Have an IoT Product? Follow Federal Labeling Requirements.

by Cooley LLP on

A device that connects wirelessly to the internet, such as a fitness tracker, smart coffee pot, or home security system, must comply with country-specific equipment authorization and labeling rules. In the US, IoT devices...more

Made-in-the-U.S.A. Complaint Does Not Make the Cut

In a case decided in December that flew beneath our radar, a judge in the Southern District of California dismissed without prejudice a proposed class action alleging that Citizens for Humanity falsely labeled its jeans as...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

by Morgan Lewis on

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

by Reed Smith on

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

by McDermott Will & Emery on

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

FDA Response to Biosimilar Naming Petitionx Just Issued

by Goodwin on

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

by Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

by King & Spalding on

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the...

As previously reported, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling. As part of the final rules, FDA defined “dietary fiber,” in...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

by DLA Piper on

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

False Labeling Lawsuits Get Hung Up On Faulty Damages Models

Food companies have several significant defenses to consumer fraud class actions over product labeling, say attorneys Joshua Briones and Crystal Lopez, and analyst Grace Rosales. The authors focus on damages, an area in which...more

TTB Publishes a Federal Register Notice Adjusting the Civil Monetary Penalty under ABLA

by McDermott Will & Emery on

On January 10, 2017, TTB published a Federal Register notice adjusting the civil monetary penalty imposed for violations of the Alcohol Beverage Labeling Act of 1988 (the ABLA). The ABLA requires the labels of alcohol...more

FDA Releases Biosimilar Naming Guidance

by Goodwin on

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

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