News & Analysis as of

Fifth Amendment › Food and Drug Administration (FDA)

Axinn, Veltrop & Harkrider LLP

Opening Another Front in the Brand/Generic Battle?

Axinn, Veltrop & Harkrider LLP on

Although it's not often that I read a decision by the U.S. Court of Federal Claims, it appears that Vanda may be opening a new front in the brand/generic battle by surviving a motion to dismiss in a case it brought under the...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

Skadden, Arps, Slate, Meagher & Flom LLP on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

The Rodman Law Group, LLC

D.C. Court Supports FDA Regulation of E-Cigs & Vape Products

The Rodman Law Group, LLC on

On 10, December 2019, the United States Court of Appeals for the D.C. Circuit ruled in support of actions by the Food and Drug Administration (“FDA”) on the regulation and classification of electronic nicotine delivery system...more

McDermott Will & Emery

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

McDermott Will & Emery on

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: October 2018

Foley Hoag LLP on

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

Patterson Belknap Webb & Tyler LLP

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

Patterson Belknap Webb & Tyler LLP on

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

Goodwin

FDA Denies AbbVie Citizen Petition on Fifth Amendment Takings

Goodwin on

On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira...more

Latham & Watkins LLP

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

Latham & Watkins LLP on

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Nossaman LLP

First Raisins, Now Tomatoes? Another Federal Government Takings Challenge

Nossaman LLP on

It appears the raisin handlers' luck in the recent U.S. Supreme Court decision Horne v. US Department of Agriculture has spawned a new federal takings challenge by another group of fruit growers. This time it's a group of...more

The Volkov Law Group

Congressional Investigations: Unique And Significant Risks

The Volkov Law Group on

We have all watched the familiar scene on Capitol Hill – the latest public scandal like officials from the Internal Revenue Service are dragged up to Capitol Hill to appear before a Committee, raise their right hands, take...more

Sheppard Mullin Richter & Hampton LLP

False Press Release Leads To Exclusion From Federal Programs

Sheppard Mullin Richter & Hampton LLP on

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

13 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide