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Life Sciences › Fifth Amendment

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

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Takes Pass on Considering IPR Constitutionality

McDonnell Boehnen Hulbert & Berghoff LLP on

There is little rhyme nor reason in the cases the Supreme Court decides to review. But the Court has patterns in its case selection that do (to some degree) probe what the Justices think are important questions. One pattern...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

Troutman Pepper

Attorney General’s Office May Weigh In on Constitutionality of IPRs involving Pre-AIA Patents

Troutman Pepper on

The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more

Patterson Belknap Webb & Tyler LLP

The FTC and LabMD’s Legal Battle Gets Personal: First Amendment Claims Against FTC Lawyers Survive

Patterson Belknap Webb & Tyler LLP on

The Federal Trade Commission’s (FTC) sprawling and contentious legal battle with now-defunct medical testing company LabMD recently took an unusual turn when a federal court allowed LabMD (and its former CEO) to proceed with...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

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