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Results: 1-10 of 60

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FDA Releases Draft Guidance on Cybersecurity Measures for Medical Devices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The U.S. Food and Drug Administration recently released draft guidance related to cybersecurity measures for medical devices.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 issues proposed guidance for social media
  • Winston & Strawn LLP
  • USA
  • June 19 2014

On Tuesday, the FDA issued proposed guidance for the pharmaceutical and medical device industries for advertising on social media platforms with


Supreme Court approves private Lanham Act Challenges to FDA-regulated food and beverage labels
  • Winston & Strawn LLP
  • USA
  • June 19 2014

In a much-anticipated decision, the Supreme Court weighed in last week on the relationship between the Lanham Act and the Food, Drug & Cosmetic Act


New class certification ruling breathes life into evaporated cane juice class action, for now
  • Winston & Strawn LLP
  • USA
  • May 29 2014

A California federal judge on May 23, 2014, certified a class of California consumers who claimed Blue Diamond Growers' almond milk product labels