News & Analysis as of

Labeling Food & Drug Regulations

Sheppard Mullin Richter & Hampton LLP

Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and...

On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more

Foley Hoag LLP

OPDP Issues Final Guidance on Best Practices for Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

Foley Hoag LLP on

On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more

Linda Liu & Partners

A brief introduction to the relationship between a drug’s generic name, trade name, and trademark

Linda Liu & Partners on

As a special product, the quality of drugs is a matter of health and safety for millions of consumers. Therefore, China has implemented strict regulations on drugs, including their names. There are three different names for...more

Bradley Arant Boult Cummings LLP

Feeling Thirsty? Wall Street, Industry Giants Stir Renewed Interest in the CBD-Beverage Market

For several years, industry giants such as Coca-Cola, PepsiCo, and Anheuser-Busch have made waves announcing future plans to explore the CBD-beverage market. And last week, Nasdaq published an article on the future of...more

Vicente LLP

Protecting Your CBD Business From Product Liability Lawsuits

Vicente LLP on

With any new consumer product craze, lawsuits will inevitably follow. The hemp-CBD industry is no exception. The current wave of CBD-related lawsuits has primarily been product liability claims. As no company wants to...more

Wilson Sonsini Goodrich & Rosati

FDA Signals a Deliberative Approach to Cannabis at Public Hearing

While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a...more

Blake, Cassels & Graydon LLP

Doing Business in Canada

This Guide provides non-Canadians with an introduction to the laws and regulations that affect the conduct of business in Canada and, in particular, in the province of Ontario. In some cases, this Guide also identifies issues...more

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