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Healthcare › Food and Drug Administration (FDA) › Off-Label Use

Foley & Lardner LLP

GLP-1 Receptor Agonists: Clinical Trial Considerations

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

Napoli Shkolnik on

Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

McDermott Will & Schulte

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

McDermott Will & Schulte on

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Troutman Pepper Locke

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

Troutman Pepper Locke 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

Hogan Lovells

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Stinson LLP

Off-Label Promotion —To Speak or Not To Speak?

Stinson LLP on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

McGuireWoods LLP

AdvaMed 2015 Highlights – Part One of Two

McGuireWoods LLP on

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

BakerHostetler

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

BakerHostetler on

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Searcy Denney Scarola Barnhart & Shipley

Is Off-Label Drug Promotion Protected Free Speech?

Searcy Denney Scarola Barnhart & Shipley on

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Patterson Belknap Webb & Tyler LLP

FDA Promises Guidance on Lawful Off-Label Promotion

Patterson Belknap Webb & Tyler LLP on

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Searcy Denney Scarola Barnhart & Shipley

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

Searcy Denney Scarola Barnhart & Shipley on

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

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