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News Bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 3 2014

The U.S. Food and Drug Administration (FDA) announces the availability of draft Guidance for Industry titled "Labeling for Human Prescription Drug

Senators seek clarity on mobile medical apps

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 3 2014

Seeking clarification on the U.S. Food and Drug Administration's (FDA's) final guidance pertaining to Mobile Medical Applications (apps), a

Court denies Myriad’s request to enjoin sale of rival BRCA1BRCA2 tests

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

A federal court in Utah has denied the request for a preliminary injunc- tion filed by Myriad Genetics against a rival company that offered tests

News Bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

The U.S. Food and Drug Administration warns Institut Biochimique sA that the Facebook Web page for one of its drugs is false or misleading "because

23andMe founder seeks to empower consumers

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

Speaking during the recently concluded SXSW festival in Austin, Texas, 23andMe co-founder Anne Wojcicki reportedly acknowledged that the U.S. Food

Company to advance diagnostics with $27-million Series B funding round

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

Exosome Diagnostics, Inc., a New York City-based developer of diagnostic tests for use in personalized medicine, has reportedly raised $27 million in

High investment interest in RNAi therapeutics

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

With investments soaring in projects exploring therapeutic applications of RNA interference (RNAi), the field has apparently begun a significant

HHS Inspector General issues report on FDA employee computer monitoring

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

The Inspector General (IG) of the U.S. Department of Human Health and services (HHs) has issued a report titled "Review of the Food and Drug

FY 2015 budget proposal underfunds life sciences research

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 20 2014

The Information Technology and Innovation Foundation (ITIF) notes that the Obama administration's fiscal year (FY) 2015 budget proposes a near

Hearing on OTC drug review scheduled

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 27 2014

The U.S. Food and Drug Administration (FDA) will conduct a public hearing on March 25-26, 2014, in silver spring, Maryland, "to obtain information