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Results: 11-20 of 605

FDA prosecutes drug importer on counterfeit drug charges

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 1 2013

The U.S. Food and Drug Administration (FDA) recently announced that a Montana resident who served as a consultant to a company that imported

FDA challenges classification of stem cell-based bone regeneration product

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

The Food and Drug Administration (FDA) has warned Parcell Laboratories that it mischaracterized its stem cell-based bone regeneration product as a human cell, tissue and cellular or tissue-based product, when the product is actually a drug or a biologic and must conform to applicable regulations

Series B funding round brings $12 million to expand clinical diagnostics products

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

Advanced Cell Dynamics, Inc. has reportedly completed a $12-million Series B equity financing round that will support the commercial expansion of the company’s RNAscope-based products and services

FDA issues guidance on acceptance of foreign clinical studies not conducted under IND

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 15 2012

The Food and Drug Administration (FDA) has issued guidance titled “Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions.”

Comments sought on Class B medical device registration guidance in Singapore

  • Shook Hardy & Bacon LLP
  • -
  • Singapore
  • -
  • June 21 2012

Singapore’s Health Sciences Authority is requesting stakeholder comments by June 28, 2012, on new guidance pertaining to the registration of Class B medical devices

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

Court finds no standing for Consumer Watchdog in stem cell patent appeal

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

The Federal Circuit Court of Appeals has rejected not-for-profit Consumer Watchdog's appeal of the U.S. Patent and Trademark Office's (USPTO's

23andMe insurer claims no duty to defend company

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

The insurance carrier that issued a "ProductsCompleted Operations Liability and Professional Liability Policy for Life Sciences" policy to 23andMe

Analysts predicts biosimilars boom as biologics reach new patent cliff

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

A new Allied Market Research (AMR) report predicts that the global biosimilars market, which accounted for $1.3 billion in 2013, will generate $35

“Purple Book” sets forth approved biologicals, will expand to biosimilars

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

The U.S. Food and Drug Administration (FDA) has released lists of reference biological products regulated by the Center for Drug Evaluation and