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Results: 11-20 of 605

FDA issues industry guidance on off-label information about drugs, medical devices

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

The Food and Drug Administration (FDA) has issued draft guidance on how the pharmaceutical and medical device industry should respond to unsolicited requests for off-label information about their FDA-approved prescription drugs and medical devices

French company prevails in dispute with FDA over drug-classification ruling

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements

European Commission proposes regulation on access to genetic resources

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • October 18 2012

To carry out European Union (EU) obligations under the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing, the European Commission (EC) has proposed a regulation that would ensure that only legally acquired genetic resources and associated traditional knowledge are used in the EU and that such resources are fairly and equitably shared

EU adds pharmaceuticals to water pollution watch list

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • July 11 2013

The European Commission (EC) has added 12 new substances to the European Union's (EU's) priority list of chemicals known to pose a risk to the safety

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 12 2014

The U.S. Food and Drug Administration (FDA) issues a final rule amending its "postmarketing safety reporting regulations for human drug and

Duke U. Economics Prof discusses prospects for biosimilars in U.S.

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 12 2014

Duke University Professor Emeritus and Director of the Program in Pharmaceutical Health Economics Henry Grabowski has co-authored a paper on

EU adopts joint procurement agreement for pandemic vaccines

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • April 17 2014

The European Commission has approved a joint procurement agreement under which all European Union (EU) member states will be able to "procure

Newsbytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 2 2014

The U.S. Patent and Trademark Office extends the deadline for applications under its Patents for Humanity Program, "which recognizes patent holders

Massachusetts Governor signs law increasing compounding pharmacy oversight

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 17 2014

Massachusetts Gov. Patrick Duval (D) has signed into law a bill (H. 4235) that will impose on compounding pharmacies new licensing, labeling

NIH awards 23andMe $1.4 million grant to build web-based database

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 7 2014

The National Institutes of Health (NIH) has awarded a $1.4 million twoyear grant to personal genome service company 23andMe. The grant is intended to