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Results: 1-10 of 38

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

India-based company’s drugs barred from U.S. market

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

The U.S. Food and Drug Administration (FDA) has prohibited imported drug products from a Ranbaxy Laboratories, Inc. facility in India due to

$100-million tentative settlement reached in meningitis outbreak from tainted steroids

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 9 2014

A settlement has reportedly been reached among litigants in multi district litigation proceedings involving the bankrupt New England Compounding

Biotech Genocea Biosciences files IPO to fund vaccine development

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 9 2014

Genocea Biosciences, Inc. has filed a registration statement with the U.S. Securities and Exchange Commission relating to a proposed initial public

India to ban PET packaging for certain pharmaceuticals

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • January 9 2014

Citing increasing concerns about potential adverse health effects, the Indian Health Ministry is reportedly considering prohibiting the use of

Consumer-fraud class action filed against 23andme after FDA action

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 12 2013

Citing the Food and Drug Administration's (FDA's) November 22, 2013, warning letter, a California resident has filed a putative class action against

FDA warns Japan-based medical equipment maker on quality controls

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 17 2013

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a Japan-based company that makes Class I and II non-sterile laser

Medical device identification system rule finalized

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 26 2013

The U.S. Food and Drug Administration (FDA) has adopted a final rule establishing a unique device identification system (UDI) that will "provide a

Settlement reached in drug contamination suit

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 26 2013

According to a news source, Nordion Inc. has settled a lawsuit in which Bioaxone Biosciences Inc. sought $90 million for the alleged contamination of