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.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 354

FDA brings successful enforcement actions against dietary supplement makers

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 1 2012

The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Truman Berst who sells, as Alternative Health & Herbs Remedies, herbs and dietary supplements with disease-treatment claims

News bytes 10 January 2013

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 10 2013

The U.S. Patent and Trademark Office (USPTO) schedules an Additive Manufacturing Partnership Meeting on January 23, 2013, at its Alexandria, Virginia

Biopharma co. seeks $90 million for tainted raw material from China

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

A biopharmaceutical company has sued companies in its supply chain, alleging they were negligent or vicariously liable for obtaining from China a raw material, contaminated with beef broth and avian products, for use in the creation of a bacterial master cell bank for the production of a biologic drug that will be used in patients with acute spinal cord injury

Universities abroad experiment with no-fee licensing to drive biotech partnerships

  • Shook Hardy & Bacon LLP
  • -
  • Australia, Canada, European Union, United Kingdom, USA
  • -
  • May 16 2013

Universities in Australia, Canada, Europe, and the United Kingdom have reportedly embraced a 2010 Glasgow University initiative under which companies

U.S. intervenes in False Claims Act suit against biotech company

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 4 2013

The U.S. government has intervened in part of a False Claims Act (FCA) lawsuit against Agave BioSystems, a biotechnology-based small business with

FDA may change conflict-of-interest rules for advisory panel members

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 4 2011

Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly told an advocacy group that scientists with financial ties to drug and device-makers may soon be allowed to advise U.S. regulators about those products

Moneytree report shows increased life sciences investments in Q1 2011

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 19 2011

According to a PricewaterhouseCoopers report on venture capital investments, although fewer deals occurred in the first quarter of 2011 (Q1 2011) as compared to the last quarter of 2010, investment activity increased 5 percent overall

Violations of discovery orders result in default judgment, monetary sanctions, potential discipline

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 18 2011

A federal court in Texas has imposed severe sanctions in a patent infringement lawsuit, due to repeated violations of its discovery orders and the creation of a fraudulent discovery-related document; a default judgment has been entered against the violator, and information about the document has been forwarded to alert the district’s chief judge “of the need to potentially take disciplinary measures” against counsel

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