We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 113

FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices
  • Drinker Biddle & Reath LLP
  • USA
  • December 21 2017

On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry


FDA Approves First Digital Pill
  • Drinker Biddle & Reath LLP
  • USA
  • November 17 2017

The U.S. Food and Drug Administration has approved the country’s first drug with a digital ingestion tracking system. Abilify MyCite is a pill that


Made in the USA: Labeling Lawsuits in America's Pet Food Industry
  • Drinker Biddle & Reath LLP
  • USA
  • March 8 2016

As of 2015, the Food & Drug Administration (FDA) had become aware of more than 5,000 reports of American dogs that became sick or died after eating


Federal court grants First Amendment injunction in Amarin case
  • Drinker Biddle & Reath LLP
  • USA
  • August 7 2015

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that "the government cannot prosecute pharmaceutical


FDA releases Draft Guidance on its Voluntary Qualified Importer Program
  • Drinker Biddle & Reath LLP
  • USA
  • July 2 2015

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program


FDA issues guidance on cybersecurity for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • November 24 2014

On October 2, the FDA issued guidance on cybersecurity for medical devices containing software in order "to assist industry by identifying issues


Recent Supreme Court decision gives competitor false advertising claims added juice
  • Drinker Biddle & Reath LLP
  • USA
  • June 17 2014

The U.S. Supreme Court recently issued an opinion that could have important consequences for lawsuits between competitors in the food and beverage


FDA releases FDASIA Health IT Report
  • Drinker Biddle & Reath LLP
  • USA
  • April 18 2014

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food


$1.2 billion Medicaid fraud penalty award reversed and claim dismissed in Arkansas appeal
  • Drinker Biddle & Reath LLP
  • USA
  • March 20 2014

In another decision narrowing the scope of state Medicaid fraud statutes, on March 20, 2014, the Supreme Court of Arkansas, inOrtho-McNeil-Janssen


New reprint Guidance maintains bipartisan status quo
  • Drinker Biddle & Reath LLP
  • USA
  • March 18 2014

The FDA’s most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses.With minor textual revisions, the