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Results: 1-10 of 34

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA
  • Latham & Watkins LLP
  • USA
  • January 5 2016

On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food & Drug Administration (FDA) had withdrawn its accusations


A look at the FDA's new social media guidance
  • Latham & Watkins LLP
  • USA
  • February 13 2014

On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing industry with long-awaited insight into how


The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the pharmaceutical and biotechnology industries
  • Latham & Watkins LLP
  • USA
  • July 16 2012

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law


Corporate officers to be prosecuted for corporate violations of the Food, Drug, and Cosmetic Act without knowledge of criminal conduct
  • Latham & Watkins LLP
  • USA
  • August 24 2011

The Food and Drug Administration (FDA) has released aggressive guidelines for prosecutions under the Food, Drug, and Cosmetic Act1 (FDCA) that put corporate officers at risk of criminal liability merely because of their position within a violating company


The Institute of Medicine recommends FDA abandon the 510(k) premarket clearance process
  • Latham & Watkins LLP
  • USA
  • August 2 2011

In September 2009, the US Food and Drug Administration (FDA or Agency) requested that the Institute of Medicine (IOM) evaluate the premarket clearance process for medical devices set forth in section 510(k) of the Federal Food, Drug and Cosmetic Act


FDA issues draft guidance for in vitro companion diagnostic devices
  • Latham & Watkins LLP
  • USA
  • July 20 2011

On July 14, 2011, the Food and Drug Administration (FDA) issued a draft guidance entitled, "In Vitro Companion Diagnostic Devices."


FDA moves to clarify nanotechnology guidelines
  • Latham & Watkins LLP
  • USA
  • June 20 2011

Nanotechnology the use of nanometer-sized particles in consumer and other products has been at the forefront of commercial innovation across several industries over the past decade, from personal care products to pharmaceuticals


An ounce of prevention: FDA issues first rules under FSMA intended to prevent unsafe food from entering the market
  • Latham & Watkins LLP
  • USA
  • June 3 2011

Recent, high profile recalls of contaminated food products have highlighted the difficulty of responding to a food safety concern after the products have made their way to consumers


Matrixx Initiatives, Inc. v. Siracusano: changes in adverse event reporting
  • Latham & Watkins LLP
  • USA
  • April 7 2011

On March 22, 2011 the US Supreme Court issued its decision in Matrixx Initiatives, Inc. v. Siracusano, in which it rejected the application of a bright-line rule that reports of adverse events related to the use of drugs and other products regulated by the US Food and Drug Administration (FDA) which do not rise to the level of statistical significance are immaterial as a matter of law under the federal securities laws


Reaffirming the patentability of medical treatment methods
  • Latham & Watkins LLP
  • USA
  • January 19 2011

On December 17, 2010, the US Court of Appeals for the Federal Circuit issued Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, F.3d , 2010 WL 5175124 (Fed. Cir. 2010), producing another significant victory for the Latham & Watkins appellate team handling the case on behalf of Prometheus