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Due Process Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

Dorsey & Whitney LLP

The Supreme Court Update - June 14, 2024

Dorsey & Whitney LLP on

On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more

Husch Blackwell LLP

Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges

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In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private...more

Holland & Knight LLP

Food and Beverage Law Update: July 2021

Holland & Knight LLP on

"The overwhelming majority of courts have concluded that neither COVID-19 nor the governmental orders associated with it cause or constitute property loss or damage for purposes of insurance coverage." So concluded the...more

Parker Poe Adams & Bernstein LLP

Public and Private Employees File First Challenges to Mandatory Vaccination Policies

In a pair of notable new lawsuits, employees of both public and private employers have filed legal challenges to mandatory COVID-19 vaccination policies. First, on April 16, 2021, in the Middle District of North Carolina, a...more

Butler Snow LLP

Revisiting “Is ‘The Government Said I Could’ A Civil Liability Defense?” During COVID-19

Butler Snow LLP on

Late last year we covered a decision finding a mine operator could not be held liable for unpermitted discharges under the Clean Water Act because it had properly disclosed them to the state permitting authority, which “chose...more

McDermott Will & Emery

Court Dismisses Challenge to TTB's Rejection of Health Claims on Vodka

In August, the US District Court for the District of Columbia issued its final decision in Bellion Spirits, LLC v. United States, Civ. No. 17-2538 (JEB). The Bellion case was brought by spirits company Bellion Spirits after...more

Foley Hoag LLP

Product Liability Update: April 2019

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First Circuit Holds Subsequent FDA Approval Of Drugs For Pediatric Use Not Conclusive Proof Of Effectiveness At Time Of Sale So As To Preclude Fraudulent Marketing Claims, And Individualized Proof Of Causation Of...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

Holland & Knight LLP on

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Foley Hoag LLP

Product Liability Update: October 2018

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First Circuit Holds Personal Jurisdiction Over Foreign Software Services Provider On Claim Arising Under Federal Law Satisfies Fifth Amendment Due Process’ Minimum Contacts Requirement Because Defendant Knowingly Conducted...more

Knobbe Martens

$50 Million Lawsuit Filed Against FDA

Knobbe Martens on

On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was filed by Semler Research Center Pvt. Ltd., a contract research...more

Clark Hill PLC

DELAYED: The FDA’s Intended Use Rule

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The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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