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Phase II of the FDA’s Transparency Initiative: the Transparency Task Force releases draft recommendations on FDA’s public disclosure policies
  • Foley Hoag LLP
  • USA
  • May 21 2010

In June 2009, Dr Margaret Hamburg, the newly appointed Commissioner of Food and Drugs, announced the Food and Drug Administration ("FDA" or "Agency") Transparency Initiative and created the FDA Transparency Task Force to carry out the Initiative.


Jump-starting biomedical research and development: the new therapeutic tax credit and cash grant program
  • Foley Hoag LLP
  • USA
  • April 30 2010

The Qualifying Therapeutic Discovery Project Tax Credit program was created by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148.


Cutting-edge research and development receives boost from health care reform: an overview of the Cures Acceleration Network
  • Foley Hoag LLP
  • USA
  • April 30 2010

As provisions of the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148, are implemented to expand coverage and improve the quality of health care, it is important for the health care industry to be aware of another provision in PPACA the Cures Acceleration Network, which will be a valuable tool to fund the development of cutting edge drugs, diagnostics, biologics, and medical devices.


New federal earmark rules will impact for-profit companies
  • Foley Hoag LLP
  • USA
  • February 1 2010

The system by which Congress awards earmarks during the annual appropriations process has recently come under increased scrutiny.


FDA releases initial draft guidance on risk evaluation and mitigation strategies (REMS): seeking input from stakeholders
  • Foley Hoag LLP
  • USA
  • October 1 2009

The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance for industry, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.”


FDA acknowledges deviations in Menaflex knee device clearance
  • Foley Hoag LLP
  • USA
  • September 25 2009

In an unusual "preliminary report" released yesterday, the Food and Drug Administration (FDA) admitted to "multiple departures from processes, procedures, and practices" in the 510(k) clearance of ReGen Biologics’ Menaflex knee repair implant, which "leaves the basis for a review decision in question."