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Results:1-10 of 39

FDA advisory committee meeting materials were “printed publications” after notice of meeting and link to location of materials were published in the Federal Register
  • Winston & Strawn LLP
  • USA
  • September 4 2018

This was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB) finding patent claims relating to a drug distribution system for


Cumberland Pharmaceuticals v. Mylan Institutional LLC, Nos. 2016-1155 and 2016-1259 (Fed. Cir. Jan. 26, 2017)
  • Winston & Strawn LLP
  • USA
  • January 3 2017

FDA request for study does not amount to derivation where study request did not clearly encompass all elements of the later issued claims


FDA to Research Drug Risk Information on Character Space Limited Social Media
  • Winston & Strawn LLP
  • USA
  • November 21 2016

On November 7, 2016, the FDA announced that it intends to conduct research as to whether links can effectively disclose prescription drug risks in


FDA Bans Common Antibacterial Agent; Will EPA Follow Suit?
  • Winston & Strawn LLP
  • USA
  • October 25 2016

On September 2, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule banning the sale of over-the-counter consumer antiseptic wash


FDA Plans to Redefine “Healthy” and Issues Guidance for the Industry
  • Winston & Strawn LLP
  • USA
  • October 11 2016

Earlier this week, the Food and Drug Administration (FDA) announced that it plans to redefine the criteria required to claim that a particular food is


Amgen Inc. v. Apotex Inc
  • Winston & Strawn LLP
  • USA
  • August 29 2016

Amgen Inc. brought an action against Apotex Inc. under the Biologics Price Competition and Innovation Act (BPCIA) alleging that Apotex’s marketing of


FDA Releases Draft Guidance on Cybersecurity Measures for Medical Devices
  • Winston & Strawn LLP
  • USA
  • March 10 2016

The U.S. Food and Drug Administration recently released draft guidance related to cybersecurity measures for medical devices. The guidance offers a


Manufacturer warned by FDA for Kardashian Instagram post about morning sickness drug
  • Winston & Strawn LLP
  • USA
  • August 17 2015

The Food and Drug Administration recently sent a warning letter to drug manufacturer Duchesnay, Inc. after Kim Kardashian posted an allegedly


FDA warning letter sent to dietary supplement manufacturers are followed by proposed class action lawsuits
  • Winston & Strawn LLP
  • USA
  • May 23 2012

Gaspari Nutrition, Inc., maker of Spirodex, a product advertised as a mood-enhancing dietary stimulant supplement, was recently hit with a proposed class action lawsuit for false advertising in the U.S. District Court for the Southern District of California.


U.S. Supreme Court unanimously upholds generic drug makers’ right to correct inaccurate brand patent descriptions
  • Winston & Strawn LLP
  • USA
  • April 18 2012

In its first-ever case construing the Hatch-Waxman Act’s provisions governing competition between generic and brand-name drug makers, the United States Supreme Court on Tuesday handed a major victory to the generic drug industry.