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Results: 1-10 of 355

FDA targets “high-risk” compounding pharmacies for inspection
  • Shook Hardy & Bacon LLP
  • USA
  • March 7 2013

The Food and Drug Administration (FDA) has reportedly begun focusing its investigative efforts on compounding pharmacies at "high risk" for


Pharmacy and hospital interests present comments on proposed compounding bill
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

Proposed legislation (S. 959) that would give the U.S. Food and Drug Administration (FDA) the authority to oversee compounding pharmacies that ship


IOM publishes report on the effects of falsified and substandard medicines
  • Shook Hardy & Bacon LLP
  • Global, USA
  • February 21 2013

At the request of the U.S. Food and Drug Administration (FDA), national think tank the Institute of Medicine (IOM) has published a report that


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