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Results: 11-20 of 355

FDA considers changes to generic drug labeling rules
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

A footnote in an amicus brief filed by the U.S. Department of Justice (DOJ) in a case involving whether a design-defect claim asserted against a


U.S. biotech sector shows IPO gains in 2013
  • Shook Hardy & Bacon LLP
  • USA
  • June 6 2013

According to Reuters, 14 biotech companies have gone public so far in 2013, marking a possible turnaround for the sector with a rising stock market


News bytes - February 21, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

The U.S. Patent and Trademark Office schedules a series of public roundtables "to solicit stakeholder input on ways the agency can reduce the number


Support growing for request that FDA freeze biosimilar applications
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

The Washington Legal Foundation (WLF), a public interest law and policy center, has filed comments with the U.S. Food and Drug Administration (FDA


State momentum to restrict use of biosimilars slows
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

Legislation in Mississippi that would have allowed pharmacists to substitute biosimilars only if they are deemed interchangeable with the prescribed


Biopharma industry survey reveals talent shortage
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

A new report based on a CEO survey reportedly cites a talent gap in the scientific workforce that has the U.S. biopharmaceutical industry taking new


Ninth Circuit to consider impact of trial court error in admitting expert testimony
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

In related cases that could have implications for intellectual property, consumer safety and complex litigation where resolution of the dispute


News Bytes - April 4, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

The U.S. Food and Drug Administration (FDA) issues draft guidance titled "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors


Hawaii Senate shelves proposal to require labels for imported GE foods
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

Three Hawaii Senate committees have deferred consideration of a House Bill (H.B. 174) that would have prohibited the sale of any "imported


FDA announces compounding pharmacy recall
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

The U.S. Food and Drug Administration (FDA) has posted on its Website a letter from a New Jersey-based pharmaceutical compounding facility recalling