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Results: 1-10 of 147

Ranbaxy loses FDA approval for two generics
  • Shook Hardy & Bacon LLP
  • USA, India
  • November 13 2014

According to a statement that Ranbaxy Laboratories Ltd. provided to the Bombay Stock Exchange Website, the U.S. Food and Drug Administration (FDA


Public watchdog calls on FDA to issue “revolving door” guidance
  • Shook Hardy & Bacon LLP
  • USA
  • October 2 2014

Public Citizen recently called on the U.S. Food and Drug Administration (FDA) to take certain steps that would both prohibit the practice of advisory


FDA contends Twitter not off limits for pharmaceutical cos.
  • Shook Hardy & Bacon LLP
  • USA
  • October 2 2014

While the U.S. Food and Drug Administration (FDA) has extended the deadline for comments on its draft guidance for drug and medical device makers


Newsbytes
  • Shook Hardy & Bacon LLP
  • USA
  • October 2 2014

The U.S. Patent and Trademark Office extends the deadline for applications under its Patents for Humanity Program, "which recognizes patent holders


FDA releases clinical trial action plan
  • Shook Hardy & Bacon LLP
  • USA
  • September 11 2014

The U.S. Food and Drug Administration (FDA) has issued a 27-point action plan aimed at improving diversity in clinical trials. While the numbers of


“Purple Book” sets forth approved biologicals, will expand to biosimilars
  • Shook Hardy & Bacon LLP
  • USA
  • September 11 2014

The U.S. Food and Drug Administration (FDA) has released lists of reference biological products regulated by the Center for Drug Evaluation and


FDA issues guidance on unique medical device ID system
  • Shook Hardy & Bacon LLP
  • USA
  • August 21 2014

The U.S. Food and Drug Administration (FDA) has issued guidance to help industry, particularly small businesses, label their medical devices in


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • August 21 2014

The U.S. Food and Drug Administration (FDA) seeks participation proposals for a pilot program involving tools that manufacturers and the agency can


Physicians urge FDA to allow distinctive names for biosimilars
  • Shook Hardy & Bacon LLP
  • USA
  • August 21 2014

A coalition of organizations representing specialist physicians and individual physicians have authored a letter to U.S. Food and Drug Administration


FDA increases drug facility fees
  • Shook Hardy & Bacon LLP
  • USA
  • August 7 2014

The U.S. Food and Drug Administration (FDA) has established fiscal year 2015 drug facility user fees that have increased 12-15 percent over current