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Results: 1-10 of 269

Sequestration impact on FDA uncertain

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 7 2013

Speaking during the Generic Pharmaceutical Association's annual conference in February 2013, Food and Drug Administration (FDA) Commissioner Margaret

House bill would impose litigation costs on losing non-practicing entities

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 7 2013

U.S. Reps. Peter DeFazio (D-Ore.) and Jason Chaffetz (R-Utah) have introduced legislation (H.R. 845) that would create a "loser pays" system in

FDA launches blog to provide insights into public health issues

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

The Food and Drug Administration (FDA) has launched a blog that, in the words of Commissioner Margaret Hamburg, will provide “insights on some of the most pressing public health issues of the day.”

N e w s b y t e s

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

The Food and Drug Administration requests comments by April 26, 2012, on its “Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k).”

Congress continues to address reauthorization of FDA user fee law

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

With a number of hearings scheduled before House committees in February 2012, Congress is apparently on track to complete work on measures that would reauthorize the Food and Drug Administration (FDA) to collect user fees before the current law expires on September 30

USPTO rolls out rulemaking notices to implement America Invents Act

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

The U.S. Patent and Trademark Office (USPTO) issued several notices in the January 5, 2012, Federal Register, concerning proposed rulemakings that would implement procedural changes required under the America Invents Act

California initiates voter petition seeking mandatory labeling on biotech foods

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

A group of environmentalists is reportedly seeking to qualify a voter initiative in California that would require special labels on foods containing genetically engineered (GE) ingredients

IPOs sluggish in 2011 on disappointing returns

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 19 2012

Biotech initial public offerings (IPOs) tracked the market as a whole in 2011, with fewer filed and returns in the negative column

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

Long-running GORE-TEX graft patent dispute fractures Federal Circuit panel

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

A divided Federal Circuit Court of Appeals panel has upheld a jury verdict of patent validity and willful infringement and affirmed a district court’s decision to enhance the damages verdict, thus upholding an award in excess of $371 million and an additional award of $19 million in costs and attorney’s fees

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