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Results: 1-10 of 54

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 13 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry and staff titled "Molecular Diagnostic Instruments with Combined

Ranbaxy loses FDA approval for two generics

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • 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

Ninth Circuit rules out state’s claims in class settlement with fetal-gender testing co

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 13 2014

The Ninth Circuit Court of Appeals has enjoined California's effort to obtain restitution on behalf of individual citizens bound by the bargainedfor

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 30 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry titled "Circumstances that Constitute Delaying, Denying, Limiting

Ninth Circuit okays pharma waste disposal ordinance

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 30 2014

The Ninth Circuit Court of Appeals has upheld the validity of an Alameda County ordinance that requires prescription drug producers that sell brand

Vaccine developer agrees to settle shareholder litigation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

A putative class action instituted by three shareholders against the nowbankrupt biotechnology company Biovest International, Inc., alleging

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

The U.S. Patent and Trademark Office (USPTO) seeks comments on the estimated time burdens of revisions to a currently approved information collection

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