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News Bytes September 2013
  • Shook Hardy & Bacon LLP
  • USA
  • September 26 2013

The National Institutes of Health (NIH) seeks comments on its draft Genomic Data Sharing (GDS) Policy that outlines the responsibilities of


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

Heads of the U.S. Patent and Trademark Office (USPTO), European Patent Office and Japan Patent Officecollectively known as the Trilateral Offices confirm their commitment to eliminating unnecessary duplication of work, enhancing patent examination and quality, and working to ensure that stable patent rights can be granted smoothly and easily worldwide.


FDA warns competing drug makers over unsubstantiated superiority claims
  • Shook Hardy & Bacon LLP
  • USA
  • November 15 2012

The U.S. Food and Drug Administration has sent warning letters to competing drug manufacturers for allegedly promoting their neonatal respiratory distress syndrome treatments using “unsubstantiated superiority claims” that also “omit and minimize important risk information, and present unsubstantiated claims for the drug product”.


Data standards partnership launched
  • Shook Hardy & Bacon LLP
  • USA
  • November 1 2012

The U.S. Food and Drug Administration (FDA) has launched a partnership with the Clinical Data Interchange Standards Consortium and Critical Path Institute to develop standardized definitions for individual diseases and the therapeutic approaches to treat them in an effort to transform the massive data streams from drug studies on specific diseases into usable information.