News & Analysis as of

Advertising Pharmaceutical Industry Clinical Trials

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - September 2023

Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Arnall Golden Gregory LLP

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

Gardner Law

Back on the Case: FDA Issues Fresh Enforcement Letters

Gardner Law on

After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Smart & Biggar

Two health advertising updates – PAAB and Meta (Facebook)

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1. PAAB’s Accelerated Review Options - In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more

Hogan Lovells

Meta ban on health-targeting ads will soon restrict clinical trial recruiters

Hogan Lovells on

A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more

Smart & Biggar

Health Canada – COVID-19 update highlights

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

Hogan Lovells

CJEU: Trademark use in clinical trials, no bar to non-use revocation

Hogan Lovells on

This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more

American Conference Institute (ACI)

[Event] FDA BOOT CAMP - March 25 - 27, 2019, New York, NY

Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more

Hogan Lovells

FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

Hogan Lovells on

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more

Patrick Malone & Associates P.C. | DC Injury...

Here’s why you’re getting those unsolicited mailings about clinical trials

When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even...more

Kelley Drye & Warren LLP

Decision Highlights Questions Over Substantiation for Weight Loss Claims

The Eleventh Circuit recently issued a decision in an contempt proceeding against Hi-Tech Pharmaceuticals and several individuals. The case highlights the ongoing debate over whether clinical trials are required for weight...more

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