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Results: 1-10 of 303

FDA issues guidance on drug shortage notification issues

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

The Food and Drug Administration (FDA) is requesting public comments on a draft guidance titled “Notification to FDA of Issues That May Result in a Prescription Drug or Biological Product Shortage.”

USPTO proposes supplemental examination rules, fees under patent reform law

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 2 2012

The U.S. Patent and Trademark Office (USPTO) has issued proposed rules of practice to implement the America Invents Act requirements for supplemental examination that take effect September 12, 2012

D.C. Circuit turns aside challenge to federal funding of stem-cell research

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 30 2012

The D.C. Circuit Court of Appeals has upheld National Institutes of Health (NIH) guidelines on federal funding of stem-cell research, finding that the agency properly interpreted the Dickey-Wicker amendment, attached as a rider to a number of federal appropriations bills, when it distinguished between research using but not creating stem cells from human embryos and allowed funding for the former but not the latter

Fractured Myriad Genetics ruling follows SCOTUS remand

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 30 2012

Ruling that one plaintiff had standing to seek a declaratory judgment as to the patent eligibility of certain genetic discoveries, the Federal Circuit Court of Appeals has once again reversed in part and affirmed in part a lower court’s determination that isolated DNA molecules and methods of comparing molecules to determine whether a patient’s genes have mutations that could cause breast and ovarian cancer were not patent eligible

FDA approves proposed rule to mark medical devices with unique identifier

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 12 2012

The U.S. Food and Drug Administration (FDA) has proposed a system that would require most medical devices distributed in the United States to carry a unique device identifier (UDI

NRDC challenges EPA grant of conditional registration for nanosilver pesticide

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 2 2012

The Natural Resources Defense Council (NRDC) has filed a petition in the Ninth Circuit Court of Appeals seeking review of a U.S. Environmental Protection Agency (EPA) order granting a conditional registration for a nanosilver antimicrobial pesticide used in clothing, baby blankets, bed sheets, and other textiles

Employment growth documented in bioscience industry development report

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 12 2012

A new report prepared by Battelle and the Biotechnology Industry Organization indicates that the bioscience industry “stands out in job growth,” and has been a job-creation leader between 2001 and 2010

Four new regional USPTO offices planned

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 12 2012

Acting U.S. Commerce Secretary Rebecca Blank has announced that regional U.S. Patent and Trademark Offices (USPTO) will be opened in or near Dallas, Texas; Denver, Colorado; and Silicon Valley, California

FDA user fee bill gains presidential signature

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 12 2012

After winning overwhelming and swift approval in the House and Senate, the Food and Drug Administration Safety and Innovation Act (S. 3187), which is expected to generate $6 billion over five years from user fees to fund the agency, has been signed into law by President Barack Obama (D

USPTO issues memo interpreting Mayo v. Prometheus labs for patent examiners

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • July 12 2012

The U.S. Patent and Trademark Office (USPTO) has issued a memorandum to its patent examining corps to communicate the agency’s 2012 interim procedure for a subject-matter eligibility-analysis of process claims involving laws of nature, in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012

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