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: 1-9 of 9

Pharmaceutical companies laud FDA’s breakthrough drug approval procedures
  • Shook Hardy & Bacon LLP
  • USA
  • September 12 2013

Since the Food and Drug Administration Safety and Innovation Act was enacted in July 2012, the Food and Drug Administration (FDA) has received 82


Federal court rejects punitive damages in bone drug litigation
  • Shook Hardy & Bacon LLP
  • USA
  • August 1 2013

A federal court in Florida has granted a drug maker's request to apply New Jersey law to the plaintiffs' punitive damages demand in litigation


Putative class alleges pharma statements about new drug violated securities laws
  • Shook Hardy & Bacon LLP
  • USA
  • May 16 2013

Aveo Pharmaceuticals, Inc. and several of its executives have been targeted in a securities class action filed in a federal court in Massachusetts


News Bytes - February 8, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • February 8 2013

The Food and Drug Administration issues guidance titled "Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and


Eighth Circuit allows investor suit to proceed against pharmaceutical co
  • Shook Hardy & Bacon LLP
  • USA
  • June 7 2012

The Eighth Circuit Court of Appeals has determined that investors alleging securities fraud against a pharmaceutical company which claimed in its Securities and Exchange Commission filings that it was in material compliance with Food and Drug Administration (FDA) regulations sufficiently pleaded that the claims were false or misleading


Drug maker brings first amendment challenge to off-label use rules
  • Shook Hardy & Bacon LLP
  • USA
  • November 3 2011

Par Pharmaceutical, Inc. has filed a declaratory judgment action against the U.S. Food and Drug Administration (FDA) in a District of Columbia federal court, seeking an order barring the agency from enforcing regulations that criminalize off-label drug promotions on the ground that they violate First Amendment free speech rights


Medical product companies ask FDA to clarify policies on off-label uses
  • Shook Hardy & Bacon LLP
  • USA
  • July 14 2011

Leading U.S. pharmaceutical and medical device manufacturers have filed a citizen petition with the Food and Drug Administration (FDA) calling on the agency to clarify its regulations and policies on off-label uses of drugs and medical devices



Chris A. Johnson
  • Shook Hardy & Bacon LLP