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FDA issues guidance on unique medical device ID system

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The U.S. Food and Drug Administration (FDA) has issued guidance to help industry, particularly small businesses, label their medical devices in

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The U.S. Food and Drug Administration (FDA) seeks participation proposals for a pilot program involving tools that manufacturers and the agency can

Guilty plea entered in cancer-drug smuggling operation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The owner of an Istanbul, Turkey-based pharmaceutical company has pleaded guilty in a Missouri federal court to charges that he shipped illegal

News bytes

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

The U.S. Patent & Trademark Office (USPTO) selects 19 law schools to join its Law School Clinic Certification Pilot Program. Four of the law schools

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

U.S. senators call on FDA to finalize biosimilars guidance

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

Five Republican U.S. senators have written to Health and Human Services (HHS) Secretary Sylvia Burwell to express concerns about the Food and Drug

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 22 2014

The U.S. Patent and Trademark Office solicits comments on the estimated time and cost burdens of the revision of a currently approved collection of

Court rules Massachusetts’s ban on painkiller preempted

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

A federal court in Massachusetts has granted a drugmaker's request to preliminarily enjoin the Commonwealth's ban on a painkiller, finding that the

U.S. lawmakers call for prompt OMB processing of electronic drug labeling rule

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 13 2014

U.S. Reps. Fred Upton (R-Mich.) and Henry Waxman (D-Calif.), and Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) have reportedly called on

Class action filed against 23andMe, Inc. over efficacy of home DNA test kits

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 30 2014

A New Mexico resident has filed a putative nationwide class action against 23andMe, Inc., alleging that claims for its DNA Collection Kits&mdash